Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00232583
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.
- Detailed Description
This is a 72 months long randomized clinical trial longitudinally evaluating beta-cell function, as well as glycemic control and inflammatory markers in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- type 2 diabetes mellitus diagnosed within the prior 2 months
- HbA1c > 7% at the time of inclusion
- willing to perform intensive diabetes management
- able to comply with treatment and follow-up regimen
- HbA1c > 8% at time of randomization
- creatinine > 1.5 mg/dl
- liver function tests > 3 times the upper limit of normal
- severe anemia
- severe proliferative retinopathy
- NYHA class III or IV heart failure
- active CAD or recent (within 6 months) MI
- pregnant, willing to get pregnant, or not willing to practice any contraceptive method
- non-english speaking
- active heavy alcohol or illicit drug users (within past 6 months)
- history of lactic acidosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metfomin and Insulin Insulin Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration Metformin, Pioglitazone and Glyburide Metfomin Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration Metformin, Pioglitazone and Glyburide Pioglitazone Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration Metformin, Pioglitazone and Glyburide glyburide Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration Metfomin and Insulin Metformin Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration
- Primary Outcome Measures
Name Time Method Beta-cell Function - C-peptide AUC (Area Under the Curve) 72 months C-peptide AUC during a 3-hours mixed meal challenge testing
- Secondary Outcome Measures
Name Time Method Insulin Sensitivity as Measure be Matsuda Index 72 months C-peptide-based Matsuda index using following formula: Matsuda index = 500,00 / root square \[(fasting c-peptide x fasting glucose x 333) x (average c-peptide 0-120 mins x average glucose 0-120 mins x 333). Higher the Matsuda index, better the insulin sensitivity.
Bet-cell Function Measured by Disposition Index 72 months Disposition index was measured by multiplying the insulin secretion (C-peptide AUC/C-peptide AUC glucose) by the Matsuda index. Disposition index reflects the beta-cell function adjusted for total body insulin sensitivity
Inflammatory Markers - PAI-1 72 months Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1)
Inflammatory Markers - hsCRP 72 months Inflammatory markers - hsCRP (C reactive protein)
Quality of Life Survey (QoL) - Hypoglycemia Fear 72 months Hypoglycemia fear was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry
Weight 72 months Body Weight
Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment 72 months Willingness to continue insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.
Inflammatory Markers -Fibrinogen 72 months Inflammatory markers - Fibrinogen
Quality of Life Survey (QoL) - Treatment Satisfaction 72 months Treatment satisfaction was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.
Quality of Life Survey (QoL) - Treatment Impact 72 months Treatment impact was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.
Quality of Life Survey (QoL) - Glycemia Control Perception 72 months Glycemia control perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled.
Quality of Life Survey (QoL) - Social Stigma 72 months Social stigma was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1- strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.
Quality of Life Survey (QoL) - Current Health Perception 72 months Current health perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.
Quality of Life Survey (QoL) - Social or Vocational Worry 72 months Social or vocational worry was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.
Quality of Life Survey (QoL) - Lifestyle Flexibility 72 months Lifestyle flexibility was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.
Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment 72 months Satisfaction with insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.
Trial Locations
- Locations (1)
University of Texas Southwestern
🇺🇸Dallas, Texas, United States