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What's new in endocrinology and diabetes mellitus
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What's new in endocrinology and diabetes mellitus
All topics are updated as new evidence becomes available and our peer review process is complete.
Literature review current through: Dec 2017. | This topic last updated: Jan 09, 2018.

The following represent additions to UpToDate from the past six months that were considered by the editors and authors to be of particular interest. The most recent What's New entries are at the top of each subsection.

DIABETES MELLITUS

Oral insulin ineffective in preventing or delaying diabetes in relatives of patients with type 1 diabetes (January 2018)

Early studies suggested that oral insulin therapy might prevent diabetes in relatives of patients with type 1 diabetes. However, subsequent trials have not shown a benefit, including a recent trial specifically designed to evaluate the role of oral insulin in relatives of patients with type 1 diabetes [1]. Participants were similar to those in the subgroup of the Diabetes Prevention Trial who had experienced apparent benefit. Over 500 insulin autoantibody-positive first or second degree relatives (median age 8.2 years) of patients with type 1 diabetes were randomly assigned to oral insulin or placebo. After a median follow-up of 2.7 years, oral insulin did not prevent or delay the development of type 1 diabetes. (See "Prevention of type 1 diabetes mellitus", section on 'Insulin'.)

ACE inhibitors and statins do not prevent moderately increased albuminuria or progression of retinopathy in type 1 diabetes (November 2017)

Angiotensin inhibition and statin therapy have been proposed as treatments to prevent microvascular complications in patients with type 1 diabetes mellitus, although evidence has not supported this hypothesis. In a 2x2 placebo-controlled trial of quinapril and atorvastatin in 443 normoalbuminuric and normotensive adolescents with type 1 diabetes, neither drug reduced the incidence of moderately increased albuminuria (primary outcome), and neither drug significantly reduced the progression of retinopathy (an exploratory outcome) [2]. Thus, UpToDate continues to recommend that angiotensin inhibition and statin therapy not be used for primary prevention of microvascular complications in type 1 diabetes. (See "Moderately increased albuminuria (microalbuminuria) in type 1 diabetes mellitus", section on 'ACE inhibitors or ARBs' and "Diabetic retinopathy: Prevention and treatment", section on 'Prevention'.)

Continuous glucose monitoring in patients with type 2 diabetes receiving multiple daily injections of insulin (October 2017)

In patients with type 1 diabetes, continuous glucose monitoring (CGM) can modestly improve glycemic control and reduce the frequency of biochemical hypoglycemia (glucose <70 mg/dL [3.9 mmol/L]). In a recent trial evaluating CGM or usual care (self-monitoring of blood glucose at least four times daily) in 158 adults with type 2 diabetes receiving multiple daily injections of insulin, the reduction in glycated hemoglobin (A1C) at 24 weeks was greater with CGM (0.8 versus 0.5 percentage points, respectively) [3]. There was no difference in hypoglycemia, which was infrequent in both groups, or in quality-of-life measures. CGM may be beneficial in selected patients with type 2 diabetes receiving multiple daily insulin injections. (See "Self-monitoring of blood glucose in management of adults with diabetes mellitus", section on 'Efficacy'.)

Continuous glucose monitoring in pregnant women with type 1 diabetes (October 2017)

Good glycemic control before and during pregnancy in women with type 1 diabetes is a key factor impacting pregnancy outcome, but whether frequent daily capillary glucose monitoring or continuous glucose monitoring (CGM) results in better glycemic control and pregnancy outcome has not been established. In two parallel open-label trials, 325 women (215 pregnant, 110 planning pregnancy) with type 1 diabetes receiving intensive insulin therapy were randomly assigned to either CGM plus capillary glucose monitoring or capillary glucose monitoring alone [4]. In women planning pregnancy, glycemic control at the end of the trial was similar in both groups. In pregnant women, glycemic control and some newborn outcomes (eg, frequency of hypoglycemia, large for gestational age) were better in the CGM group. Although the improvement in neonatal hypoglycemia with CGM appears promising, the lack of blinding may have biased decisions regarding neonatal management. Also, it is unclear whether the high level of maternal compliance with CGM in this trial could be achieved in other populations. (See "Pregestational diabetes mellitus: Glycemic control during pregnancy", section on 'Self-monitoring of blood glucose'.)

Sotagliflozin as adjunctive therapy for type 1 diabetes (October 2017)

Sotagliflozin, an investigational dual sodium-glucose co-transporter (SGLT) 1 and 2 inhibitor, was evaluated as an adjunct to insulin therapy in 1400 patients with type 1 diabetes who were randomly assigned to sotagliflozin or placebo [5]. After 24 weeks, the proportion of patients who achieved a glycated hemoglobin (A1C) <7 percent and no severe hypoglycemia or diabetic ketoacidosis was greater in the sotagliflozin group (28.6 versus 15.2 percent). However, the rate of diabetic ketoacidosis was higher in the sotagliflozin group (3 versus 0.6 percent) as was the frequency of dehydration and genital infections. Whether the increased risk for treatment-related complications is balanced by the modest lowering of A1C is unclear. (See "Management of blood glucose in adults with type 1 diabetes mellitus", section on 'Adjunctive therapy'.)

SGLT2 inhibitors and risk of acute kidney injury (October 2017)

In postmarketing reports, sodium-glucose co-transporter 2 (SGLT2) inhibitors used for the treatment of type 2 diabetes have been associated with acute kidney injury, with some patients requiring hospitalization and dialysis. However, a recent analysis of two different cohorts of diabetic patients, including both SGLT2 users and nonusers, did not show an increased risk of acute kidney injury [6]. Nevertheless, renal function should be assessed prior to initiation of SGLT2 inhibitors and monitored during treatment. (See "Sodium-glucose co-transporter 2 inhibitors for the treatment of type 2 diabetes mellitus", section on 'Acute kidney injury'.)

Roux-en-Y gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (September 2017)

Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) comprise over 95 percent of bariatric procedures performed in patients with type 2 diabetes in North America, but the optimal procedure to maximize glycemic control is unclear. In one study, diabetes remission (glycated hemoglobin [A1C] <6.5 percent off medications) was achieved in 49 percent of patients after RYGB and 28 percent after SG at a median of seven years [7]. By classifying diabetes preoperatively as mild, moderate, or severe by a nomogram based on four variables, the authors found that RYGB resulted in a higher rate of diabetes remission than SG for patients with moderate diabetes and a similar rate as SG for those with mild diabetes. For patients with severe diabetes, both procedures had low rates of diabetes remission. We believe the choice between RYGB and SG should be based on clinical factors in addition to glucose control, such as the patient's overall surgical risk and whether the patient has severe acid reflux, Crohn disease, or requires organ transplantation. (See "Laparoscopic sleeve gastrectomy", section on 'Diabetes mellitus'.)

Liraglutide and renal outcomes in type 2 diabetes (September 2017)

In an earlier report of a randomized trial comparing liraglutide with placebo in patients with type 2 diabetes and coexisting cardiovascular disease, liraglutide reduced the incidence of the composite cardiovascular endpoint. In a separate analysis of the secondary microvascular endpoints in the trial, liraglutide reduced the incidence of the renal outcome (a composite of new-onset persistent macroalbuminuria, persistent doubling of the serum creatinine level, end-stage renal disease, or death due to renal disease) [8]. The results were driven by a lower incidence of new-onset persistent macroalbuminuria. Trials of longer duration with primary microvascular outcomes and in patients who are not at high cardiovascular risk are required in order to better understand the microvascular effects of GLP-1 receptor agonists. (See "Glucagon-like peptide-1 receptor agonists for the treatment of type 2 diabetes mellitus", section on 'Microvascular outcomes'.)

Effect of insulin degludec and insulin glargine on hypoglycemia and CVD outcomes (July 2017)

Long-acting basal insulin preparations include glargine, detemir, and degludec. Several recent studies have compared outcomes for insulin degludec and insulin glargine.

In two similarly designed crossover trials comparing once-daily insulin degludec with insulin glargine in patients with type 1 and type 2 diabetes mellitus at high risk for hypoglycemia, the rate of overall symptomatic and nocturnal hypoglycemia was lower with degludec [9,10]. Limitations of the trials include a high rate of loss to follow-up and lack of generalizability to patients at lower risk for hypoglycemia.

In a two-year noninferiority trial comparing once-daily insulin degludec with insulin glargine in over 7500 patients with type 2 diabetes and cardiovascular disease, the primary cardiovascular composite outcome (death from cardiovascular causes, or first occurrence of a nonfatal myocardial infarction or nonfatal stroke) occurred in a similar proportion of patients (8.5 and 9.3 percent of the patients receiving degludec and glargine, respectively) [11]. Glycemic control was similar throughout the trial; rates of severe and nocturnal hypoglycemia were lower in patients taking degludec.

The choice of basal insulin (NPH, glargine, detemir, or degludec) primarily depends upon patient preference, lifestyle, and cost issues. (See "Insulin therapy in type 2 diabetes mellitus", section on 'Cardiovascular effects' and "Insulin therapy in type 2 diabetes mellitus", section on 'Basal insulin' and "Management of blood glucose in adults with type 1 diabetes mellitus", section on 'Basal insulin'.)

Racial variation in glycated hemoglobin (July 2017)

Several studies have shown that glycated hemoglobin (A1C) concentrations are higher in black than in white persons with diabetes, although it is uncertain if the difference is due to worse glycemic control or racial variation in the glycation of hemoglobin. In a prospective, 12-week study comparing A1C with mean glucose values measured by continuous glucose monitoring (CGM) in black and white persons with type 1 diabetes, both average CGM glucose (191 versus 180 mg/dL [10.6 versus 10 mmol/L]) and A1C (9.1 versus 8.3 percent) were higher in black than white individuals [12]. The mean A1C in black compared with white individuals was 0.4 percentage points higher for any given mean glucose concentration. The racial variation explained only a proportion of the difference in mean A1C levels between the two groups, with higher mean glucose values likely accounting for the rest. The small difference in A1C has not been shown to modify the association between A1C and microvascular and macrovascular outcomes, and diagnostic criteria and target A1C goals remain unchanged. (See "Estimation of blood glucose control in diabetes mellitus", section on 'Racial variation'.)

FEMALE REPRODUCTION

Updated guidelines for the management of gender dysphoria/gender incongruence in adolescents and adults (October 2017)

The Endocrine Society has released updated guidelines for the treatment of gender dysphoria/gender incongruence [13]. The new guidelines replace the term "transsexual" with "gender dysphoria" or "gender incongruence" and specify detailed professional qualifications for clinicians who diagnose, assess, or treat individuals with gender dysphoria/gender incongruence. They continue to recommend the management and monitoring of transgender adolescents and adult men and women by a multidisciplinary team, as well as counseling patients about the time course of hormone-induced physical changes and options for fertility preservation. We agree with the updated guidelines. (See "Transgender women: Evaluation and management", section on 'Standards of care'.)

Ovarian biomarkers for predicting ability to conceive (October 2017)

Serum anti-Müllerian hormone (AMH) and follicle stimulation hormone (FSH) levels are commonly measured to assess ovarian reserve in women wishing to conceive. However, a large prospective cohort study of women age 30 to 44 years, without a history of infertility, reported similar conception rates for women with normal and abnormal AMH and FSH levels [14]. This study adds to the body of evidence suggesting that AMH and FSH levels do not predict the probability of pregnancy in women without a diagnosis of infertility, even among women of older age. The study did not address conception rates for women with a known diagnosis of infertility. For women in this age group with known infertility who are considering in vitro fertilization, these tests do have some prognostic value. (See "Evaluation and management of infertility in women of advancing age", section on 'Diminished ovarian reserve'.)

Polycystic ovary syndrome: No role for metformin in ovulation induction (September 2017)

Metformin was widely used in the past for women with polycystic ovary syndrome (PCOS) for ovulation induction and prevention of miscarriage, multiple gestations, and pregnancy complications. However, the American Society for Reproductive Medicine now suggests that there is insufficient evidence to recommend metformin for any of these indications [15]. Unlike the first-line ovulation induction agents letrozole and clomiphene, which improve live birth rates, metformin increases ovulatory rates and pregnancy rates, but not live birth rates. (See "Metformin for treatment of the polycystic ovary syndrome", section on 'Anovulatory infertility'.)

Fertility preservation with cryopreserved ovarian tissue transplantation (July 2017)

For women at risk of ovarian failure due to planned gonadotoxic therapy and who desire fertility preservation, increasing evidence supports use of ovarian tissue cryopreservation followed by autotransplantation (OTT) after completion of therapy. In a 2017 meta-analysis, endocrine function was restored for at least four months after OTT in over 60 percent of women [16]. OTT was associated with similar live birth rates as conventional frozen embryo transfer, and over 60 percent of women who conceived after an orthotopic transplant conceived naturally. (See "Fertility preservation in patients undergoing gonadotoxic treatment or gonadal resection", section on 'Outcomes'.)

Menopausal hot flashes: A novel nonhormonal treatment (July 2017)

A neurokinin 3 receptor (NK3R) antagonist is a potential new nonhormonal therapy for menopausal hot flashes. In a randomized, crossover trial of an oral NK3R antagonist or placebo administered for four weeks each in symptomatic postmenopausal women, the average total weekly number of hot flashes decreased from approximately 85 at baseline to 20 and 50 in the treatment and placebo groups, respectively [17]. Residual hot flashes in the treatment group were also less severe and less bothersome. Three subjects in the treatment group had transient increases in transaminases that were asymptomatic and returned to baseline post-trial. Although results of this trial are encouraging, larger and longer duration trials are needed to determine the efficacy and safety of this drug. (See "Menopausal hot flashes", section on 'Neurokinin 3 receptor antagonist'.)

MALE REPRODUCTION

Selective androgen receptor modulators: Composition of products sold on the internet (November 2017)

Selective androgen receptor modulators (SARMs) are a class of compounds that have become popular as performance-enhancing drugs. None are approved for use, but many SARM products are sold via the internet, the majority with inaccurate labeling. In a study of 44 SARM products purchased from the internet and analyzed using procedures approved by the World Anti-Doping Agency, only 18 had accurate labeling (eg, they contained the correct SARM and dosage) [18]. Four products contained no active compounds at all, and the remainder were inaccurately labeled (most had at least one additional unapproved drug or substance [eg, growth hormone secretagogues and/or androgens]). (See "Use of androgens and other hormones by athletes", section on 'SARMs'.)

Updated guidelines for the management of gender dysphoria/gender incongruence in adolescents and adults (October 2017)

The Endocrine Society has released updated guidelines for the treatment of gender dysphoria/gender incongruence [13]. The new guidelines replace the term "transsexual" with "gender dysphoria" or "gender incongruence" and specify detailed professional qualifications for clinicians who diagnose, assess, or treat individuals with gender dysphoria/gender incongruence. They continue to recommend the management and monitoring of transgender adolescents and adult men and women by a multidisciplinary team, as well as counseling patients about the time course of hormone-induced physical changes and options for fertility preservation. We agree with the updated guidelines. (See "Transgender women: Evaluation and management", section on 'Standards of care'.)

OSTEOPOROSIS

Romosozumab for the treatment of postmenopausal osteoporosis (September 2017)

Romosozumab, an investigational sclerostin inhibitor, was compared with alendronate in a trial in over 4000 postmenopausal women with osteoporosis and a prior fragility fracture [19]. The experimental group received romosozumab monthly for 12 months followed by weekly alendronate for an additional 12 months; the control group received alendronate alone for 24 months. Radiographic vertebral fractures, as well as clinical fractures (nonvertebral and hip) were less frequent in the romosozumab group, but serious cardiovascular events (cardiac ischemia and stroke) occurred more commonly in the romosozumab group (0.8 versus 0.3 percent). Further investigation is warranted. (See "Overview of the management of osteoporosis in postmenopausal women", section on 'Emerging therapies'.)

Bisphosphonates not protective against breast cancer in postmenopausal women (August 2017)

Although some studies have suggested a protective effect of bisphosphonates against breast cancer, others, including a large observational cohort of over 64,000 postmenopausal women followed for approximately seven years [20], have not. Studies may be confounded by the frequent use of bisphosphonates to treat osteoporosis, and women with osteoporosis are more likely to have a lower estrogen environment and therefore a lower baseline risk of breast cancer regardless of bisphosphonate exposure. (See "Factors that modify breast cancer risk in women", section on 'Bisphosphonates'.)

THYROID DISORDERS

Levothyroxine not beneficial for euthyroid women with TPO antibodies who are undergoing IVF (January 2018)

An increased risk of adverse pregnancy outcomes, including early pregnancy loss, has been reported in euthyroid women with elevated thyroid peroxidase (TPO) antibody concentrations. Thyroid hormone replacement in such women who are undergoing assisted reproductive technologies (ART) does not appear to reduce the risk of early pregnancy loss. In a trial evaluating levothyroxine or no treatment in 600 euthyroid Chinese women with TPO antibodies who were undergoing in vitro fertilization with embryo transfer, there was no difference in the miscarriage or live birth rates [21]. For euthyroid pregnant women with TPO antibodies who are not undergoing ART, thyroid hormone treatment to prevent the development of hypothyroidism during pregnancy and reduce the risk of early pregnancy loss is controversial. (See "Overview of thyroid disease in pregnancy", section on 'Effect of T4 treatment'.)

Birth rate after radioiodine for the treatment of differentiated thyroid cancer (November 2017)

Radioiodine (RAI) is administered after thyroidectomy in selected patients with differentiated thyroid cancer. Transient amenorrhea may occur following therapy, but subsequent infertility is rare. In a cohort study of over 2000 women diagnosed with differentiated thyroid cancer between the ages of 15 and 39 years, treatment with RAI, compared with no RAI, was not associated with a reduced birth rate [22]. (See "Differentiated thyroid cancer: Radioiodine treatment", section on 'Gonadal function and fertility'.)

Thyroid hormone assay interference with biotin supplements (October 2017)

A growing number of reports have noted that ingestion of 5 to 10 mg of biotin (marketed over the counter to prevent hair loss) can cause artifactually low serum thyroid stimulating hormone (TSH) and high triiodothyronine (T3) and thyroxine (T4) in assays using biotin-streptavidin affinity systems in their design [23,24]. Thyroid tests should be repeated at least two days after discontinuation of biotin supplements. (See "Laboratory assessment of thyroid function", section on 'Assay interference with biotin ingestion'.)

VITAMIN D

Vitamin D and all-cause mortality in patients with advanced heart failure (August 2017)

Some, but not all, observational studies suggest that low 25-hydroxyvitamin D levels (especially <10 to 20 ng/mL [25 to 50 nmol/L]) are associated with higher mortality. There are few randomized trials of vitamin D supplementation with mortality as a primary endpoint. In one such trial, vitamin D supplementation (4000 international units daily for three years) compared with placebo did not reduce overall mortality in patients with advanced heart failure and baseline vitamin D levels <30 ng/dL (75 nmol/L) [25]. (See "Vitamin D and extraskeletal health", section on 'Mortality'.)

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REFERENCES

  1. Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group, Krischer JP, Schatz DA, et al. Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial. JAMA 2017; 318:1891.
  2. Marcovecchio ML, Chiesa ST, Bond S, et al. ACE Inhibitors and Statins in Adolescents with Type 1 Diabetes. N Engl J Med 2017; 377:1733.
  3. Beck RW, Riddlesworth TD, Ruedy K, et al. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med 2017; 167:365.
  4. Feig DS, Donovan LE, Corcoy R, et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet 2017; 390:2347.
  5. Garg SK, Henry RR, Banks P, et al. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med 2017; 377:2337.
  6. Nadkarni GN, Ferrandino R, Chang A, et al. Acute Kidney Injury in Patients on SGLT2 Inhibitors: A Propensity-Matched Analysis. Diabetes Care 2017; 40:1479.
  7. Aminian A, Brethauer SA, Andalib A, et al. Individualized Metabolic Surgery Score: Procedure Selection Based on Diabetes Severity. Ann Surg 2017; 266:650.
  8. Mann JFE, Ørsted DD, Brown-Frandsen K, et al. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med 2017; 377:839.
  9. Lane W, Bailey TS, Gerety G, et al. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. JAMA 2017; 318:33.
  10. Wysham C, Bhargava A, Chaykin L, et al. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial. JAMA 2017; 318:45.
  11. Marso SP, McGuire DK, Zinman B, et al. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med 2017; 377:723.
  12. Bergenstal RM, Gal RL, Connor CG, et al. Racial Differences in the Relationship of Glucose Concentrations and Hemoglobin A1c Levels. Ann Intern Med 2017; 167:95.
  13. Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2017; 102:3869.
  14. Steiner AZ, Pritchard D, Stanczyk FZ, et al. Association Between Biomarkers of Ovarian Reserve and Infertility Among Older Women of Reproductive Age. JAMA 2017; 318:1367.
  15. Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org, Practice Committee of the American Society for Reproductive Medicine. Role of metformin for ovulation induction in infertile patients with polycystic ovary syndrome (PCOS): a guideline. Fertil Steril 2017; 108:426.
  16. Pacheco F, Oktay K. Current Success and Efficiency of Autologous Ovarian Transplantation: A Meta-Analysis. Reprod Sci 2017; 24:1111.
  17. Prague JK, Roberts RE, Comninos AN, et al. Neurokinin 3 receptor antagonism as a novel treatment for menopausal hot flushes: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet 2017; 389:1809.
  18. Van Wagoner RM, Eichner A, Bhasin S, et al. Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet. JAMA 2017; 318:2004.
  19. Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med 2017; 377:1417.
  20. Fournier A, Mesrine S, Gelot A, et al. Use of Bisphosphonates and Risk of Breast Cancer in a French Cohort of Postmenopausal Women. J Clin Oncol 2017; 35:3230.
  21. Wang H, Gao H, Chi H, et al. Effect of Levothyroxine on Miscarriage Among Women With Normal Thyroid Function and Thyroid Autoimmunity Undergoing In Vitro Fertilization and Embryo Transfer: A Randomized Clinical Trial. JAMA 2017; 318:2190.
  22. Anderson C, Engel SM, Weaver MA, et al. Birth rates after radioactive iodine treatment for differentiated thyroid cancer. Int J Cancer 2017; 141:2291.
  23. Li D, Radulescu A, Shrestha RT, et al. Association of Biotin Ingestion With Performance of Hormone and Nonhormone Assays in Healthy Adults. JAMA 2017; 318:1150.
  24. Sharma A, Baumann NA, Shah P. Biotin-Induced Biochemical Graves Disease: A Teachable Moment. JAMA Intern Med 2017; 177:571.
  25. Zittermann A, Ernst JB, Prokop S, et al. Effect of vitamin D on all-cause mortality in heart failure (EVITA): a 3-year randomized clinical trial with 4000 IU vitamin D daily. Eur Heart J 2017; 38:2279.
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