Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
ConditionGestational Diabetes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAnna Stanhewicz, PhD
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥12 weeks and ≤5 years postpartum
history of GDM or healthy pregnancy
Disqualifiers
prediabetes or diabetes (HbA1c ≥5.7%)
current tobacco use
cardiovascular or metabolic disease
cardiovascular or metabolic medication
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin Hydrochloride
Drug12 weeks: 850mg metformin once daily for first 7 days then twice daily for the remaining 11 weeks.
placebo
Other intervention12 weeks: placebo tablet once daily for the first 7 days then twice daily for the remaining 11 weeks.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: metforminActive comparator 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
blood flow response to acetylcholine
cutaneous microvascular dilation (cutaneous conductance ; %max) response to acetylcholine
Time frame
baseline2
blood flow response to acetylcholine
cutaneous microvascular dilation (cutaneous conductance ; %max) response to acetylcholine
Time frame
1 week of treatment3
blood flow response to acetylcholine
cutaneous microvascular dilation (cutaneous conductance ; %max) response to acetylcholine
Time frame
6 weeks of treatment4
blood flow response to acetylcholine
cutaneous microvascular dilation (cutaneous conductance ; %max) response to acetylcholine
Time frame
12 weeks of treatmentSecondary outcomes
1
Percentage of nitric oxide-dependent dilation
NO-dependent (%) cutaneous microvascular dilation response to acetylcholine
Time frame
baseline2
Percentage nitric oxide-dependent dilation
NO-dependent (%) cutaneous microvascular dilation response to acetylcholine
Time frame
1 week of treatment3
Percentage of nitric oxide-dependent dilation
NO-dependent (%) cutaneous microvascular dilation response to acetylcholine
Time frame
6 weeks of treatment4
Percentage of nitric oxide-dependent dilation
NO-dependent (%) cutaneous microvascular dilation response to acetylcholine
Time frame
12 weeks of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anna Stanhewicz, PhD
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov