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

Non-Insulin-Dependent Diabetes Mellitus Clinical Trial

Official title:

Effect of Dietary Fiber on Glucose, Lipid, and Mineral Metabolism in Patients With Non Insulin Dependent Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825383
• Other study ID #: DF498
• Status: Completed
• Phase: N/A
• First received: January 19, 2009
• Last updated: June 19, 2013
• Start date: January 1993
• Est. completion date: December 1995

Study information

• Verified date: June 2013
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 1995
• Est. primary completion date: December 1995
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Non-Insulin-Dependent Diabetes Mellitus

Intervention

Other:
• High Fiber and Moderate Fiber Diets
Dietary

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose and lipid metabolism		Baseline and during the last 5 days of each 6 week dietary phase	No
Secondary	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	No