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

NCT ID: NCT00825383

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-01-31

Study Completion Date

1995-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Non-Insulin-Dependent Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

High Fiber Diet

Group Type ACTIVE_COMPARATOR

High Fiber and Moderate Fiber Diets

Intervention Type OTHER

Dietary

2

Moderate Fiber Diet

Group Type ACTIVE_COMPARATOR

High Fiber and Moderate Fiber Diets

Intervention Type OTHER

Dietary

Interventions

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High Fiber and Moderate Fiber Diets

Dietary

Intervention Type OTHER

Other Intervention Names

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Dietary Fiber Study

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Abhimanyu Garg

Professor, Chairman Division Nutrition & Metabolic Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abhimanyu Garg

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center at Dallas

References

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Shah M, Chandalia M, Adams-Huet B, Brinkley LJ, Sakhaee K, Grundy SM, Garg A. Effect of a high-fiber diet compared with a moderate-fiber diet on calcium and other mineral balances in subjects with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):990-5. doi: 10.2337/dc09-0126. Epub 2009 Mar 11.

Reference Type DERIVED
PMID: 19279300 (View on PubMed)

Other Identifiers

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DF498

Identifier Type: -

Identifier Source: org_study_id

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