Recruiting
Early Phase 1

Metformin

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT05917587

Conditions

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Metformin Hydrochloride

placebo

Study Details

Brief summary:

The purpose of this investigation is to examine the mechanisms mediating vascular dysfunction in women who have had gestational diabetes and how metformin may be a valuable treatment tool to improve microvascular function in these women before the onset of disease.

Conditions

Gestational Diabetes

Study ID

NCT05917587

Start date

Sep 11, 2024

Status verified date

May, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ≥12 weeks and ≤5 years postpartum
  • history of GDM or healthy pregnancy

Exclusion Criteria:

  • prediabetes or diabetes (HbA1c ≥5.7%)
  • current tobacco use
  • cardiovascular or metabolic disease
  • cardiovascular or metabolic medication
  • history of hypertension during pregnancy
  • current pregnancy

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: metformin

placebo comparator: placebo

Interventions

Metformin Hydrochloride

12 weeks: 850mg metformin once daily for first 7 days then twice daily for the remaining 11 weeks.

placebo

12 weeks: placebo tablet once daily for the first 7 days then twice daily for the remaining 11 weeks.

Primary outcome measure

  • blood flow response to acetylcholine [ Time Frame: baseline ]
  • blood flow response to acetylcholine [ Time Frame: 1 week of treatment ]
  • blood flow response to acetylcholine [ Time Frame: 6 weeks of treatment ]
  • blood flow response to acetylcholine [ Time Frame: 12 weeks of treatment ]
  • blood flow response to insulin [ Time Frame: baseline ]
  • blood flow response to insulin [ Time Frame: 1 week of treatment ]
  • blood flow response to insulin [ Time Frame: 6 weeks of treatment ]
  • blood flow response to insulin [ Time Frame: 12 weeks of treatment ]

Central Contacts and Locations

Central contacts

Anna Stanhewicz, PhD

3194671732anna-stanhewicz@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Anna Stanhewicz, PhD

319-467-1732anna-stanhewicz@uiowa.edu

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

  • gestational diabetes
  • postpartum
  • vascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2025-05-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.