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

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00825383

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

MedlinePlus related topics: Diabetes Dietary Fiber Diets Minerals

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Effect of Dietary Fiber on Glucose, Lipid, and Mineral Metabolism in Patients With Non Insulin Dependent Diabetes Mellitus

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
1: Active Comparator High Fiber Diet	Other: High Fiber and Moderate Fiber Diets Dietary
2: Active Comparator Moderate Fiber Diet	Other: High Fiber and Moderate Fiber Diets Dietary

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

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

Keywords provided by University of Texas Southwestern Medical Center:

Diabetes
lipids
fiber

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009