RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Placebo-controlled, Double Blind Trial of Semaglutide 1mg (Ozempic®) on Regression to Normoglycemia in WomEn With a Recent History of Gestational diabETes Mellitus: The SWEET Study

Quick Facts

Study Start:2022-01-13

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04873050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Female 2. 18 - 45 years old (inclusive) 3. History of gestational diabetes in most recent pregnancy 4. 6 - 36 months 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	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

Inclusion Criteria

Exclusion Criteria

1. Female
2. 18 - 45 years old (inclusive)
3. History of gestational diabetes in most recent pregnancy
4. 6 - 36 months 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

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

Contacts and Locations

Study Contact

Donna Shaler, BS

CONTACT

225-231-5268

Donna.Shaler@womans.org

Karen Elkind-Hirsch, PhD

CONTACT

2259245278

karen.elkind-hirsch@womans.org

Principal Investigator

Elizabeth Sutton, PhD

PRINCIPAL_INVESTIGATOR

Woman's Hospital, Louisiana

Study Locations (Sites)

Woman's Hospital

Baton Rouge, Louisiana, 70817

United States

Collaborators and Investigators

Sponsor: Woman's

Elizabeth Sutton, PhD, PRINCIPAL_INVESTIGATOR, Woman's Hospital, Louisiana

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-13

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2022-01-13

Study Completion Date2025-08-01

Terms related to this study

Additional Relevant MeSH Terms

Pre Diabetes
Postpartum Disorder