Status:
COMPLETED
Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
25-59 years
Phase:
PHASE4
Brief Summary
Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (T1D). The purpose of this study is to measure the effect of metformin on insulin sensit...
Eligibility Criteria
Inclusion
- Age 20-59 years of age,
- Type 1 diabetes based on antibody-positivity, rapid persistent conversion to insulin requirement after diagnosis, absent C-peptide, or DKA at diagnosis, or a clinical course consistent with T1D,
- HbA1c 6.0 - 9.5, and
- Willing and able to commit to two 6 week-long periods of blinded medication followed by hyperinsulinemic euglycemic clamp, vascular testing, and muscle biopsies.
Exclusion
- Any comorbid condition associated with:
- inflammation,
- insulin Resistance, or
- dyslipidemia including:
- cancer,
- heart failure,
- active or end stage liver disease,
- kidney disease, or
- rheumatological disease;
- Tobacco use;
- Pregnancy or women who are breastfeeding;
- Steroid use;
- Scheduled strenuous physical activity \>3 days a week;
- Angina, known CAD, or any other cardiovascular or pulmonary disease;
- A history of COPD or asthma;
- Presence of systolic blood pressure \>190 at rest or \>250 with exercise, or diastolic pressure \>95 at rest or \>105 with exercise;
- Untreated thyroid disease;
- Proteinuria (urine protein \>200 mg/dl) or a creatinine \> 1.5 mg/dl (males) or 1.4 mg/dL (females), suggestive of severe renal disease;
- Severe Proliferative retinopathy;
- Niacin treatment;
- Administration of experimental agent for T1D within 30 days prior to screening;
- Recent (prior 6 months) or current metformin or thiazolidenedione use;
- Hypoglycemia unawareness or recurrent severe hypoglycemia (no symptoms of hypoglycemia with FSBS\<40 and episodes of this severity \>1 per week);
- Weight instability (weight change \>5% in last 6 months);
- History of any organ transplant, including islet cell transplant;
- Current or prior infection with HIV, hepatitis B or hepatitis C or hepatic -insufficiency (AST or ALT \> 2x the upper limits of normal);
- Any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject;
- History of substance abuse within the 12 months prior to screening.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2017
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01813929
Start Date
June 1 2011
End Date
March 24 2017
Last Update
January 21 2022
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045