Effect of Fiber Supplementation in Children With Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT01399892 |
Recruitment Status
:
Completed
First Posted
: July 22, 2011
Last Update Posted
: July 22, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Dietary Supplement: soluble fiber in the form of benefiber | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Fiber Supplementation on Glycemic Excursions and Incidence of Hypoglycemia in Children With Type 1 Diabetes |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | December 2010 |

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Dietary Supplement: soluble fiber in the form of benefiber
- incidence of hypoglycemia after fiber supplementation [ Time Frame: continuous glucose monitoring over 72 hours ]

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Ages Eligible for Study: | 4 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399892
Principal Investigator: | Aida N Lteif, MD | Mayo Clinic |
Responsible Party: | Aida Lteif, MD, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01399892 History of Changes |
Other Study ID Numbers: |
08-002142 |
First Posted: | July 22, 2011 Key Record Dates |
Last Update Posted: | July 22, 2011 |
Last Verified: | July 2011 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |