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

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00825383
First received: January 19, 2009
Last updated: January 20, 2009
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention
Non-Insulin-Dependent Diabetes Mellitus
 Other: High Fiber and Moderate Fiber Diets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Dietary Fiber on Glucose, Lipid, and Mineral Metabolism in Patients With Non Insulin Dependent Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • glucose and lipid metabolism [ Time Frame: Baseline and during the last 5 days of each 6 week dietary phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: January 1993
Study Completion Date: December 1995
Primary Completion Date: December 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
High Fiber Diet
 Other: High Fiber and Moderate Fiber Diets
Dietary
Other Name: Dietary Fiber Study
Active Comparator: 2
Moderate Fiber Diet
 Other: High Fiber and Moderate Fiber Diets
Dietary
Other Name: Dietary Fiber Study

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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825383

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Abhimanyu Garg UT Southwestern Medical Center at Dallas
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Abhimanyu Garg, M.D., UT Southwestern Medical Center Dallas
ClinicalTrials.gov Identifier: NCT00825383     History of Changes
Other Study ID Numbers: DF498
Study First Received: January 19, 2009
Last Updated: January 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Diabetes
lipids
fiber

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013