CClinicalTrials.gg
CompletedNCT00825383Updated Jun 21, 2013

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

An interventional study of High Fiber and Moderate Fiber Diets in Non-Insulin-Dependent Diabetes Mellitus, sponsored by University of Texas Southwestern Medical Center. Completed. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Non-Insulin-Dependent Diabetes Mellitus

Keywords

  • Diabetes
  • lipids
  • fiber
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 13 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • NIDDM
  • age 35 to 80 years
  • stable oral hypoglycemic treatment for at least one month
  • fasting triglycerides \< 500 mg/dl

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Active comparator
    1

    High Fiber Diet

    Other: High Fiber and Moderate Fiber Diets

  • Active comparator
    2

    Moderate Fiber Diet

    Other: High Fiber and Moderate Fiber Diets

Interventions

  • OtherHigh Fiber and Moderate Fiber Diets

    Dietary

    Also known as: Dietary Fiber Study

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19279300 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00825383
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Abhimanyu Garg (Professor, Chairman Division Nutrition & Metabolic Diseases, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Jan 21, 2009
Start date
Jan 1993
Primary completion
Dec 1995
Completion
Dec 1995
Last update
Jun 21, 2013

Study contacts

Abhimanyu Garg
principal investigator · UT Southwestern Medical Center at Dallas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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