- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00308373
Effects of Fats on Blood Glucose in People With and Without Type 2 Diabetes Mellitus
January 19, 2010 updated by: Mayo Clinic
Effects of Elevated Free Fatty Acids on Endogenous Glucose Production in People With and Without Type 2 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert A. Rizza, M.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
March 27, 2006
First Submitted That Met QC Criteria
March 27, 2006
First Posted (Estimate)
March 29, 2006
Study Record Updates
Last Update Posted (Estimate)
January 20, 2010
Last Update Submitted That Met QC Criteria
January 19, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1104-04
- DK29953-FFA/TZD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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