Phase 2
N=28
Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance
Type 2 Diabetes · Insulin Resistance · Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00443755 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Change From Baseline in Insulin Sensitivity as Measured by Glucose Infusion Rate (GIR) — 17.95; 1.68 micromols/kg of FFM/minute — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- metformin (Drug); pioglitazone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Insulin Sensitivity as Measured by Glucose Infusion Rate (GIR) |
17.95; 1.68 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose Level |
-19.96; 8.39 | <0.001 sig |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.35; 0.19 | 0.02 sig |
| SECONDARY Change From Baseline in Insulin Levels |
-8.13; 1.38 | <0.001 sig |
| SECONDARY Change From Baseline in Lipid Profile |
-15.58; 17.77; 4.33; -0.31; -7.50; 4.62 | 0.03 sig |
| SECONDARY Change From Baseline in the Thrombotic Biomarker Fibrinogen |
14.00; -18.62 | 0.23 |
| SECONDARY Change From Baseline in the Thrombotic Biomarker Plasminogen Activator Inhibitor-1 (PAI-1) |
-34.17; 8.15 | 0.002 sig |
| SECONDARY Change From Baseline in the Inflammatory Biomarker Interleukin 6 (IL-6) |
-0.99; -1.42 | 0.13 |
| SECONDARY Change From Baseline in the Inflammatory Biomarker C-Reactive Protein (CRP) |
-0.19; -0.15 | 0.05 |
| SECONDARY Change From Baseline in Inflammatory Biomarker Tumor Necrosis Factor-alpha (TNF-α) |
-0.13; 0.18 | 0.02 sig |
| SECONDARY Change From Baseline in the Inflammatory Biomarker Adiponectin |
9.10; 0.46 | <0.001 sig |
Summary
The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.
Eligibility Criteria
Inclusion criteria
- We will study 30 patients with Type 2 Diabetes or impaired fasting glucose (15 men & 15 women) who are > 20 years old.
- Only patients who use lifestyle modification to manage their diabetes and are not on any oral hypoglycemic agents or insulin will be included.
- We will enroll subjects who have fasting glucose concentration greater than 100 mg/dl on two consecutive occasions and have a Body Mass Index between 27-36 kg/m^2.
Exclusion Criteria
- We will exclude patients whose blood glucose is above 180 mg/dl. This will avoid the need to perform home glucose monitoring and the potential of unblinding the study by the volunteers.
- Patients taking oral hypoglycemic agents or insulin would be excluded.
- Any diseases such as active cardiovascular disease, liver diseases, kidney failure (males with serum creatinine >= 1.5mg/dl, females >=1.4 mg/dl), active endocrinopathies, debilitating chronic disease, anemia, symptoms of undiagnosed illness, history of alcoholism (alcohol use > 4oz/day) or substance abuse, chronic neurological diseases including Alzheimer's disease, stroke, etc, myopathies or any other active disease that may potentially affect the outcome measures.
- Patients on medicines such as beta blockers, corticosteroids, tricyclics, benzodiazepines, opiates, barbiturates, anticoagulants and any other drugs or preparations that may affect mitochondrial function will be excluded.
- People allergic to any of the class of drug such as lidocaine will also be excluded.
- People with pacemakers, certain aneurysm clips and claustrophobia will also be excluded as they cannot undergo magnetic resonance imaging.
Data sourced from ClinicalTrials.gov (NCT00443755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.