Effect of Dietary Fiber on Glucose & Lipids in Non Insulin Dependent Diabetes Mellitus (NIDDM)

Not Applicable

Completed

• Conditions: Non-Insulin-Dependent Diabetes Mellitus
• Interventions: Other: High Fiber and Moderate Fiber Diets

• Registration Number: NCT00825383
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non insulin dependent diabetes mellitus.

Detailed Description

Two diets will be compared,a low fiber diet and a high fiber diet. These two diets will differ only in the content of total dietray fiber derived from natural food products. The diets will be identical in terms of total energy, percentage of total energy as proteins, fat and carbohydrates.

Study Timeline

• Study Start: 1993-01
• Primary Completion: 1995-12
• Study Completion: 1995-12
• Study First Submitted: 2009-01-19
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• NIDDM
• age 35 to 80 years
• stable oral hypoglycemic treatment for at least one month
• fasting triglycerides < 500 mg/dl

Exclusion Criteria

• insulin dependent NIDDM
• insulin dependent diabetes
• hepatic disease
• significant hepatic dysfunction
• signifiacnt renal dysfunction
• presence of significant hematological, neurological, cardiovascular or gastrointestinal disorder, unless stable for past 6 months,
• serious intercurrent illness or anticipated major surgery
• female pregnant or likely to become pregnant
• chronic drug abuse, alcoholism or psychaitric disorder within the past 2 years
• treated with beta adrenergic blockers
• on lipid lowering drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	High Fiber and Moderate Fiber Diets	High Fiber Diet
2	High Fiber and Moderate Fiber Diets	Moderate Fiber Diet

Primary Outcome Measures

Name	Time	Method
glucose and lipid metabolism	Baseline and during the last 5 days of each 6 week dietary phase

Secondary Outcome Measures

Name	Time	Method
calcium isotope absorption in the gastrointestinal tract, stool mineral content, 24 h urinary mineral concentration, and serum chemistry including mineral concentration.	Baseline and during the last 5 days of each 6 week dietary phase