Status:
RECRUITING
Treatment to Regress to Normoglycemia in Women with a Recent History of GDM
Lead Sponsor:
Woman's
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Pre Diabetes
Postpartum Disorder
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling ...
Detailed Description
The diagnosis of gestational diabetes mellitus (GDM) during pregnancy identifies young women with abnormalities in pancreatic beta cell function that worsen over time, leading to diabetes. It is estim...
Eligibility Criteria
Inclusion
- Female
- 18 - 45 years old (inclusive)
- History of gestational diabetes in most recent pregnancy
- 6 months - 10 years postpartum
- BMI ≥ 25 kg/m2
- Use of long-acting reversible contraception or bilateral tubal ligation
- Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):
- Fasting glucose 100-125mg/dL (inclusive) and/or
- 120 minute glucose 140-199mg/dL (inclusive)
- Willingness to maintain physical activity level throughout study duration
- Willingness to standardize diet for 3 days prior to OGTT
- Ability to provide informed consent before any trial-related activities
Exclusion
- Body weight \> 350lb
- Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.
- Breastfeeding within 3 months of screening visit 1
- Post-menopausal
- Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)
- Use of tobacco products within past 6 months
- Substance or alcohol abuse
- 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)
- 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
- History of bariatric surgery
- 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
- Use of medications for anti-obesity or weight loss within four weeks of screening visit 1
- Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1
- Known or suspected allergy to trial medication, excipients, or related products
- 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)
- Current or recent past (within 3 months) participation in another experimental drug trial
- Previous randomization in this trial
- Receipt of any investigational drug within 6 months prior to this trial
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04873050
Start Date
January 13 2022
End Date
March 1 2026
Last Update
March 13 2025
Active Locations (1)
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1
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817