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Completed

NCT Number: NCT00825383

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

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

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Key information

Conditions

Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Fiber and Moderate Fiber Diets

Other

Dietary

Other names: Dietary Fiber Study

Primary outcomes

  1. glucose and lipid metabolism

    Time frame: Baseline and during the last 5 days of each 6 week dietary phase

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
1993
Primary completion
1995
Study completion
1995
First posted
Jan 21, 2009
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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