NCT04873050 Treatment to Regress to Normoglycemia in Women with a Recent History of GDM
| NCT ID | NCT04873050 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Woman's |
| Condition | Pre Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2022-01-13 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 102 participants in total. It began in 2022-01-13 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.
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
Contact & Investigator
Elizabeth Sutton, PhD
PRINCIPAL INVESTIGATOR
Woman's Hospital, Louisiana
Frequently Asked Questions
Who can join the NCT04873050 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Pre Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04873050 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04873050 currently recruiting?
Yes, NCT04873050 is actively recruiting participants. Contact the research team at briasha.jones@womans.org for enrollment information.
Where is the NCT04873050 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT04873050 clinical trial?
NCT04873050 is sponsored by Woman's. The principal investigator is Elizabeth Sutton, PhD at Woman's Hospital, Louisiana. The trial plans to enroll 102 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.