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Effect of Fiber Supplementation in Children With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01399892
First received: July 20, 2011
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

High fiber foods are recommended as a preferential source of carbohydrate by the Nutrition Study Group of the European Association for the Study of Diabetes. Dietary fibers may delay glucose absorption and reduce postprandial glycemic excursion. They also appear to have a beneficial effect on cholesterol levels. It has been shown, in few short term adult studies, that high fiber foods reduce postprandial blood glucose levels. The American Diabetes Association feels that there is little evidence confirming the positive effect of high fiber foods on blood glucose control. It is not clear whether a high fiber diet can improve glycemic control and/or reduce the risk of hypoglycemic events. Our hypothesis is that children with type 1 diabetes will benefit from having added fibers in their diet. The investigators plan to study blood glucose values using a continuous blood glucose monitor before and after dietary fibers are introduced. This will help us determine whether a diet rich in fiber should be recommended in all children with type 1 diabetes mellitus


Condition Intervention
Type 1 Diabetes
 Dietary Supplement: soluble fiber in the form of benefiber

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Fiber Supplementation on Glycemic Excursions and Incidence of Hypoglycemia in Children With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • incidence of hypoglycemia after fiber supplementation [ Time Frame: continuous glucose monitoring over 72 hours ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: soluble fiber in the form of benefiber
    Benefiber, sugar free in an amount to total 20gms/1000kcal/day of fiber
  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria are: Diagnosis of type I diabetes for at least two years prior to enrollment, the ability tolerate wearing the continuous blood glucose monitoring device for a total of 6 days, and the ability to follow a prescribed meal plan.

Exclusion Criteria:

  • The exclusion criteria are: Medical conditions that could potentially affect the absorption of nutrients such as celiac disease of inflammatory bowel disease and the use of any fiber supplements at home.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399892

Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Aida N Lteif, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Aida Lteif, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01399892     History of Changes
Other Study ID Numbers: 08-002142
Study First Received: July 20, 2011
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013