Effects of Fats on Blood Glucose in People With and Without Type 2 Diabetes Mellitus

NCT00308373 | Completed

• 2 other identifiers: 1104-04DK29953-FFA/TZD
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

People with type 2 diabetes mellitus (earlier known as maturity onset diabetes mellitus) have high blood levels of sugar and fat. This study is being done to determine if excessive sugar entering the blood in people with type 2 diabetes mellitus is caused by excessive fat. We will also evaluate how the anti-diabetic medications, pioglitazone and metformin taken by mouth work to control blood sugar in people with diabetes.

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin vs Thiazolidinedione (Pioglitazone) DRUG

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Forty-two (21 women, 21 men) diabetic and 31 (16 women, 15 men) matched non-diabetic volunteers will be recruited. Diabetic volunteers whose HbA1c is 7-9% if managed with diet alone or 6.5-8.5% if on either a sulfonylurea or metformin will be eligible for the study. Diabetic and non-diabetic subjects will be healthy and matched for age, gender, and body mass index. Individuals with a body mass index less than 19 or greater than 44 kg/m2 will be excluded from study to avoid potential confounding effects that may result from extreme leanness or obesity. Subjects greater than age 35 years of age will be eligible for study. Subjects less than 35 years will not be studied in order to minimize the possibility of type 1 diabetes. Healthy diabetic subjects will mean that the participant has no history of a) proliferate retinopathy; b) significant nephropathy, (i.e., plasma creatinine \> 1.4 mg/dl in women and 1.5 mg/dl in men, and/or proteinuria); c) symptomatic autonomic neuropathy; d) clinically significant atherosclerotic vascular disease (e.g., history of MI or angina); e) a known systemic illness. To ensure subjects are healthy, following informed written consent, subjects will undergo a history and physical examination; blood will be collected for a complete blood count and chemistry group; urine will be collected to insure there is no evidence of infection or clinically significant proteinuria. Body composition (including percent fat, visceral fat, hepatic fat, and lean body mass) will be measured in eligible subjects in the GCRC body composition core using DEXA and a multiple cut CT scan. (Diabetic volunteers will again undergo body composition studies in Part 2 of the protocol, after about 4 months of therapy. Please see below)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert A. Rizza, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 29, 2006
• Study Start: July 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

US (1)