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

June 19, 2013 updated by: Abhimanyu Garg, University of Texas Southwestern Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
High Fiber Diet
Other: High Fiber and Moderate Fiber Diets
Dietary
Other Names:
  • Dietary Fiber Study
Active Comparator: 2
Moderate Fiber Diet
Other: High Fiber and Moderate Fiber Diets
Dietary
Other Names:
  • Dietary Fiber Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glucose and lipid metabolism
Time Frame: Baseline and during the last 5 days of each 6 week dietary phase
Baseline and during the last 5 days of each 6 week dietary phase

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Abhimanyu Garg, UT Southwestern Medical Center at Dallas

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.

General Publications

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

January 1, 1993

Primary Completion (Actual)

December 1, 1995

Study Completion (Actual)

December 1, 1995

Study Registration Dates

First Submitted

January 19, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF498

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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