Metformin and Vascular Function in Prediabetes

NCT06526494 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 202403617
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to investigate whether metformin improves vascular function in individuals with prediabetes. The main questions it aims to answer are:

1. 1.Does metformin improve large conduit artery endothelial function in individuals with prediabetes?
2. 2.Does metformin improve microvascular endothelial function in individuals with prediabetes?

Conditions

PreDiabetes

Keywords

vascular function; metformin; prediabetes

Outcome Measures

Primary Outcomes (1)

• Macrovascular endothelial function

  Brachial artery flow-mediated dilation

  12 weeks

Secondary Outcomes (1)

• Microvascular endothelial function

  12 weeks

Study Arms (2)

Metformin

EXPERIMENTAL

Participants will receive metformin 850 mg PO once a day for 2 weeks. After 2 weeks, participants will receive metformin 1700 mg PO once a day for the remaining 10 weeks.

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Patients will receive placebo pill identical in appearance and taste to the supplement

Other: Placebo

Interventions

Metformin DRUG

Oral ingestion for 12 weeks

Metformin

Placebo OTHER

Oral placebo for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-55 years
• Prediabetes defined as an HbA1c between 5.7% and 6.4%
• Able to provide informed consent

You may not qualify if:

• Current use of metformin or metformin use within the past 12 months
• Current use of medicated contraindicated for use with metformin
• Current use of vitamin C supplement
• Current smoker or quit smoking within the last 6 months
• Pregnant, breastfeeding, planning to become pregnant, or unwilling to use adequate birth control
• Uncontrolled hypertension (Systolic blood pressure \>140 mmHg)
• Body Mass Index \> 40 kg/m2
• History of diabetes, myocardial infarction, heart failure, liver disease, or chronic kidney disease (estimated glomerular filtration rate \< 45 ml/min/1.73m2)
• History of lactic acidosis
• History of alcohol abuse
• Severe infection within the last 30 days
• Immunosuppressive therapy within the past year
• Life expectancy \< 1 year
• Allergy to metformin, nitroglycerin, sodium nitroprusside, ringer's lactate
• Study compliance: Unwilling to fast overnight, have an intravenous catheter placed, take a study drug for 12 weeks, or visit Iowa campus 6 times within a 12-16 week period

Sponsors & Collaborators

• Diana Jalal: lead

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52245, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Diana I Jalal, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: November 13, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)