Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Sep 2024
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedStudy Start
First participant enrolled
September 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 13, 2025
May 1, 2025
3.3 years
June 6, 2023
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
blood flow response to acetylcholine
cutaneous microvascular dilation (cutaneous conductance ; %max) response to acetylcholine
baseline
blood flow response to acetylcholine
cutaneous microvascular dilation (cutaneous conductance ; %max) response to acetylcholine
1 week of treatment
blood flow response to acetylcholine
cutaneous microvascular dilation (cutaneous conductance ; %max) response to acetylcholine
6 weeks of treatment
blood flow response to acetylcholine
cutaneous microvascular dilation (cutaneous conductance ; %max) response to acetylcholine
12 weeks of treatment
blood flow response to insulin
cutaneous microvascular dilation (cutaneous conductance ; %max) response to insulin
baseline
blood flow response to insulin
cutaneous microvascular dilation (cutaneous conductance ; %max) response to insulin
1 week of treatment
blood flow response to insulin
cutaneous microvascular dilation (cutaneous conductance ; %max) response to insulin
6 weeks of treatment
blood flow response to insulin
cutaneous microvascular dilation (cutaneous conductance ; %max) response to insulin
12 weeks of treatment
Secondary Outcomes (4)
Percentage of nitric oxide-dependent dilation
baseline
Percentage nitric oxide-dependent dilation
1 week of treatment
Percentage of nitric oxide-dependent dilation
6 weeks of treatment
Percentage of nitric oxide-dependent dilation
12 weeks of treatment
Study Arms (2)
metformin
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
12 weeks: 850mg metformin once daily for first 7 days then twice daily for the remaining 11 weeks.
12 weeks: placebo tablet once daily for the first 7 days then twice daily for the remaining 11 weeks.
Eligibility Criteria
You may qualify if:
- ≥12 weeks and ≤5 years postpartum
- history of GDM or healthy pregnancy
You may not qualify if:
- prediabetes or diabetes (HbA1c ≥5.7%)
- current tobacco use
- cardiovascular or metabolic disease
- cardiovascular or metabolic medication
- history of hypertension during pregnancy
- current pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Stanhewicz, PhD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 26, 2023
Study Start
September 11, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Findings from the primary studies will be published and submitted to PubMed Central in compliance with the NIH public access policy. These findings will also be made public through the clinicaltrial.gov record. The final data set will be stripped of any identifying data prior to release for sharing. We will make the data and any associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to identify any one individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after all analyses are completed.