A Prospective Study of Associations of Changes in HbA1C and Fasting Blood Lipids Due to Treatment With Pioglitazone for 6 Months and Genetic Polymorphism's in PPAR-gamma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 326
- Primary Endpoint
- Change from baseline in glycosylated hemoglobin.
Study Overview
Brief Summary
The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (QD), treatment.
Detailed Description
The metabolic control in type 2 diabetes mellitus can be measured by means of glycosylated hemoglobin. A low value glycosylated hemoglobin indicates a good metabolic control, and has been shown to be associated with a better prognosis regarding diabetic complications. Type 2 diabetes is a disease with a profound genetic component. Peroxisome proliferator-activated receptor gamma is a transcription factor implicated in adipocyte differentiation, lipid and glucose metabolism. Peroxisome proliferator-activated receptor alfa is a transcription factor implicated in lipid oxidation and gluconeogenesis and is present in liver, kidney, heart, skeletal muscle and adipose tissue.
Pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors, members of the super family of ligand activated transcription factors. Specifically, thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism. These include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle.
This is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fulfills all requirements for treatment with pioglitazone.
- •Willing to start treatment with pioglitazone.
Exclusion Criteria
- •Has previously participated in this study.
- •Is currently taking or have taken oral antidiabetic medications other than sulfonylurea or metformin within the last 30 days.
Arms & Interventions
Pioglitazone 30 mg QD + Metformin
Intervention: Pioglitazone and metformin (Drug)
Pioglitazone 15 mg QD + Sulphonylurea
Intervention: Pioglitazone and sulphonylurea (Drug)
Pioglitazone 30 mg QD + Sulphonylurea
Intervention: Pioglitazone and sulphonylurea (Drug)
Pioglitazone 15 mg QD + Metformin
Intervention: Pioglitazone and metformin (Drug)
Outcomes
Primary Outcomes
Change from baseline in glycosylated hemoglobin.
Time Frame: 6 months
Secondary Outcomes
- Change from baseline in beta-cell function (Homeostasis model assessment).(End of Treatment)
- Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).(End of Treatment)
- Change from baseline in Body Weight.(End of Treatment)
- Percentage of treatment responders defined as a patient with 0.6% decrease in HbA1C from baseline visit to final visit or accomplishment of a HbA1c value at or below 6.5%.(End of Treatment)
- Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).(End of Treatment)
- Change from baseline in insulin resistance (Homeostasis model assessment).(End of Treatment)