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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00308373
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

The ultimate goal of this application is to determine the cause(s) of type 2 diabetes mellitus. The role of the liver in the evolution of type 2 diabetes has not been as extensively studied as that of muscle. This has been, in part, due to the inherent difficulty of measuring hepatic insulin action in humans under physiologic conditions. Plasma free fatty acids (FFA) can cause insulin resistance in non-diabetic humans and are commonly elevated in people with type 2 diabetes. We will re-examine the mechanism(s) by which elevated FFA cause hepatic insulin resistance in non-diabetic humans, will determine whether elevated FFA alter insulin induced suppression of endogenous glucose production (EGP) in diabetic humans and if so, whether this is due to changes in glycogenolysis and/or gluconeogenesis. We will also seek to determine whether treatment with a pioglitazone (a thiazolidinedione) blunts or prevents FFA induced hepatic (and extrahepatic) insulin resistance in people with type 2 diabetes and whether the effects of FFA on insulin action are influenced by gender. We will examine if use of thiazolidinediones reduces cortisol production by changing the overall activity of 11 beta hydroxysteroid dehydrogenase type 1. We will also investigate whether use of thiazolidinediones alters objectively measured breathing or sleepiness in people with type 2 diabetes.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-29
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-19
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States