Treatment to Regress to Normoglycemia in Women with a Recent History of GDM

Launched by WOMAN'S · Apr 29, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a medication called semaglutide (sold as Ozempic®) in helping women who have recently given birth and have a history of gestational diabetes (GDM) to return their blood sugar levels to normal. The study is aimed at women aged 18 to 45 who are between 6 to 36 months postpartum and have been diagnosed with dysglycemia, which means their blood sugar levels are not quite right. By participating, women may receive support to help lower their risk of developing type 2 diabetes in the future.

Eligible participants must be female, have a BMI of 25 or higher, and be willing to maintain a consistent level of physical activity and follow a specific diet during the study. It's important to note that women who are pregnant, breastfeeding, or have certain health conditions won't be able to join. Those who participate can expect to be monitored for their blood sugar levels and receive guidance throughout the trial, which can help fill a gap in treatment options for postpartum diabetes recovery.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female
• • 2. 18 - 45 years old (inclusive)
• • 3. History of gestational diabetes in most recent pregnancy
• • 4. 6 months - 10 years postpartum
• • 5. BMI ≥ 25 kg/m2
• • 6. Use of long-acting reversible contraception or bilateral tubal ligation
• 7. Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):
• • 1. Fasting glucose 100-125mg/dL (inclusive) and/or
• • 2. 120 minute glucose 140-199mg/dL (inclusive)
• • 8. Willingness to maintain physical activity level throughout study duration
• • 9. Willingness to standardize diet for 3 days prior to OGTT
• • 10. Ability to provide informed consent before any trial-related activities
• Exclusion Criteria:
• • 1. Body weight \> 350lb
• • 2. Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.
• • 3. Breastfeeding within 3 months of screening visit 1
• • 4. Post-menopausal
• • 5. Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)
• • 6. Use of tobacco products within past 6 months
• • 7. Substance or alcohol abuse
• • 8. Presence of significant systemic disease including: diabetes mellitus (type 1 or type 2), cardiac disease (e.g. congestive heart failure), renal impairment (e.g. serum creatinine levels ≥ 1.4 mg/dL or eGFR \< 60), hepatic disease (including viral hepatitis, toxic hepatic damage, jaundice of unknown aetiology, or abnormal liver function tests), pancreatitis, uncontrolled thyroid disease (e.g. documented abnormal TSH), adrenal disease (including Cushing's syndrome, congenital adrenal hyperplasia), hyperlipidemia (fasting triglycerides \> 399mg%), untreated or poorly controlled hypertension (resting blood pressure \>159/94 mmHg)
• • 9. History of or presence of: eating disorder, malignant disease requiring chemotherapy, or debilitating psychiatric disorder such as psychosis or neurological condition that could confound outcome variables
• • 10. History of bariatric surgery
• • 11. Use of medications for glucose regulation: insulin (e.g. Humalog, Novolog, Humulin), pramlintide, metiglinides, metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors within four weeks of screening visit 1
• • 12. Use of medications for anti-obesity or weight loss within four weeks of screening visit 1
• • 13. Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1
• • 14. Known or suspected allergy to trial medication, excipients, or related products
• • 15. Contraindications to study medications: patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• • 16. Current or recent past (within 3 months) participation in another experimental drug trial
• • 17. Previous randomization in this trial
• • 18. Receipt of any investigational drug within 6 months prior to this trial