Actively Recruiting

Phase 4
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT04873050

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

Led by Woman's · Updated on 2025-03-13

102

Participants Needed

1

Research Sites

215 weeks

Total Duration

On this page

Sponsors

W

Woman's

Lead Sponsor

N

Novo Nordisk A/S

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • 18 - 45 years old (inclusive)
  • History of gestational diabetes in most recent pregnancy
  • 6 months - 10 years postpartum
  • Body mass index (BMI) of 25 kg/m2 or higher
  • Using long-acting reversible contraception or have had bilateral tubal ligation
  • Dysglycemia shown by impaired fasting glucose (100-125 mg/dL) and/or impaired glucose tolerance (140-199 mg/dL) on a 2-hour oral glucose tolerance test
  • Willing to maintain physical activity level during the study
  • Willing to standardize diet for 3 days before glucose testing
  • Able to provide informed consent before starting the study
Not Eligible

You will not qualify if you...

  • Body weight over 350 pounds
  • Pregnant, planning to become pregnant, or not using adequate contraception
  • Breastfeeding within 3 months before screening
  • Post-menopausal
  • Planning pregnancy during the study or within two months after it ends
  • Use of tobacco products in past 6 months
  • Substance or alcohol abuse
  • Significant systemic diseases including type 1 or 2 diabetes, heart failure, kidney or liver disease, pancreatitis, uncontrolled thyroid or adrenal diseases, high triglycerides, or uncontrolled hypertension
  • History of eating disorder, cancer needing chemotherapy, or serious psychiatric or neurological disorders
  • History of bariatric surgery
  • Use of glucose-regulating medications (like insulin, metformin, GLP-1 receptor agonists) within 4 weeks before screening
  • Use of weight loss or anti-obesity drugs within 4 weeks before screening
  • Use of medications that worsen glucose control (such as isotretinoin or corticosteroids) within 4 weeks before screening
  • Known or suspected allergy to study medication or related products
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2
  • Participation in another experimental drug trial within past 3 months
  • Previous randomization in this trial
  • Use of any investigational drug within 6 months before this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Woman's Hospital

Baton Rouge, Louisiana, United States, 70817

Actively Recruiting

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Research Team

B

Briasha Jones, MPH

CONTACT

E

Elizabeth Sutton, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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