Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes
Overview[ - collapse ][ - ]
Purpose | 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 sensitivity, vascular function and compliance, and mitochondrial function in T1D. The long term goal is to identify novel non-glycemic approaches to managing cardiovascular disease risk in T1D. The results of this study may validate a novel approach to T1D treatment that could significantly improve current management of cardiovascular disease risk in this high risk population. |
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Condition | Type 1 Diabetes |
Intervention | Drug: Metformin Drug: Placebo |
Phase | Phase 4 |
Sponsor | University of Colorado, Denver |
Responsible Party | University of Colorado, Denver |
ClinicalTrials.gov Identifier | NCT01813929 |
First Received | September 28, 2012 |
Last Updated | March 14, 2013 |
Last verified | March 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 28, 2012 |
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Last Updated Date | March 14, 2013 |
Start Date | June 2011 |
Estimated Primary Completion Date | June 2014 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes |
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Official Title | Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes |
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 sensitivity, vascular function and compliance, and mitochondrial function in T1D. The long term goal is to identify novel non-glycemic approaches to managing cardiovascular disease risk in T1D. The results of this study may validate a novel approach to T1D treatment that could significantly improve current management of cardiovascular disease risk in this high risk population. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 1 Diabetes |
Intervention | Drug: Metformin Six week intervention: study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily. Other Names: glucophageDrug: Placebo Six-week intervention: Placebo will be given in a forced uptitration with 500 mg once daily for one week, twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 100 |
Estimated Completion Date | June 2014 |
Estimated Primary Completion Date | June 2014 |
Eligibility Criteria | Inclusion Criteria: 1. age 20-59 years of age, 2. 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, 3. HbA1c 6.0 - 9.5, and 4. 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 Criteria: - Any comorbid condition associated with inflammation, IR, 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 |
Gender | Both |
Ages | 25 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Nicholas Birdsey, BS 303-877-3511 nicholas.birdsey@ucdenver.edu |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01813929 |
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Other Study ID Numbers | 11-0693 |
Has Data Monitoring Committee | No |
Information Provided By | University of Colorado, Denver |
Study Sponsor | University of Colorado, Denver |
Collaborators | Department of Veterans Affairs |
Investigators | Principal Investigator: Irene Schauer, MD, PhD University of Colorado, Denver |
Verification Date | March 2013 |
Locations[ + expand ][ + ]
University of Colorado Denver | Aurora, Colorado, United States, 80045 Contact: Nathaniel Solis, BS | 303-724-6634 | nathaniel.solis@ucdenver.eduPrincipal Investigator: Irene Schauer, MD, PhD Recruiting |
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