Non-Insulin-Dependent Diabetes MellitusNCT00825383
Effect of Dietary Fiber on Glucose & Lipids in Non Insulin Dependent Diabetes Mellitus (NIDDM)
A study testing High Fiber and Moderate Fiber Diets in people with Non-Insulin-Dependent Diabetes Mellitus, run by University of Texas Southwestern Medical Center.
Trial summary
Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non insulin dependent diabetes mellitus. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Non-Insulin-Dependent Diabetes Mellitus
- What is being tested?
- High Fiber and Moderate Fiber Diets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 1993to Dec 1995
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NIDDM
- age 35 to 80 years
- stable oral hypoglycemic treatment for at least one month
- fasting triglycerides < 500 mg/dl
Who cannot join
- 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,
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- 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
About this study
Official title: Effect of Dietary Fiber on Glucose, Lipid, and Mineral Metabolism in Patients With Non Insulin Dependent Diabetes Mellitus
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.
- Conditions
- Non-Insulin-Dependent Diabetes Mellitus
- Being tested
- High Fiber and Moderate Fiber Diets
- Keywords
- Diabetes, lipids, fiber
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fiber and Moderate Fiber DietsOther
Also called Dietary Fiber Study
Dietary
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | High Fiber Diet Receives: Other: High Fiber and Moderate Fiber Diets |
| 2 | Active comparator | Moderate Fiber Diet Receives: Other: High Fiber and Moderate Fiber Diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose and lipid metabolism
Measured: 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.
Measured: Baseline and during the last 5 days of each 6 week dietary phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 1993
- Primary completionDec 1995
- Study completionDec 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Insulin-Dependent Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhimanyu Garg, University of Texas Southwestern Medical Center
- Investigators
- Abhimanyu Garg, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825383
- Sponsor's protocol ID
- DF498
- Status last verified
- Jun 2013
- First submitted
- 19 Jan 2009
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Fiber on Glucose, Lipid, and Mineral Metabolism in Patients With Non Insulin Dependent Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00825383
- Acronym / sponsor ID
- DF498
- Conditions
- Non-Insulin-Dependent Diabetes Mellitus
- Keywords
- Diabetes, lipids, fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 1993
- Primary completion
- Dec 1995 (actual)
- Study completion
- Dec 1995 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non insulin dependent diabetes mellitus.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: High Fiber and Moderate Fiber DietsHigh Fiber Diet |
| 2 | Active comparator | Other: High Fiber and Moderate Fiber DietsModerate Fiber Diet |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NIDDM
- age 35 to 80 years
- stable oral hypoglycemic treatment for at least one month
- fasting triglycerides < 500 mg/dl
Key exclusion criteria (11 listed)
- insulin dependent NIDDM
- insulin dependent diabetes
- hepatic disease
- significant hepatic dysfunction
- signifiacnt renal dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Fiber and Moderate Fiber DietsAlso: Dietary Fiber StudyDietary | Other | 1, 2 |
Primary outcome
glucose and lipid metabolism
Time frame: Baseline and during the last 5 days of each 6 week dietary phase
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Derived from this study: PubMed 19279300Shah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhimanyu Garg principal investigator
UT Southwestern Medical Center at Dallas
Questions about this trial
What is this clinical trial studying?
A study testing High Fiber and Moderate Fiber Diets in people with Non-Insulin-Dependent Diabetes Mellitus, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose and lipid metabolism (time frame: Baseline and during the last 5 days of each 6 week dietary phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.