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Tracking Information | |||||
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First Received Date † | May 22, 2008 | ||||
Last Updated Date | June 4, 2008 | ||||
Start Date † | May 2008 | ||||
Current Primary Outcome Measures † |
Post-Prandial metabolism [ Time Frame: Early morning - Midafternoon ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00691249 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Satiety [ Time Frame: Early morning - Midafternoon ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes | ||||
Official Title † | Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes | ||||
Brief Summary | This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes. |
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Detailed Description | To measure the blood glucose response, after an overnight fast, blood samples will be collected before eating and 15, 30, 45, 60, 90, and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index. We will also measure the second meal effect by measuring the metabolic response (glucose, insulin, and gut hormones) after a standardized lunch two hours following the first assessment. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Supportive Care, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study | ||||
Condition † | Hyperglycemia | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 10 | ||||
Estimated Completion Date | February 2009 | ||||
Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00691249 | ||||
Responsible Party | Mark Haub Ph.D., Department of Human Nutrition | ||||
Secondary IDs †† | |||||
Study Sponsor † | Kansas State University | ||||
Collaborators †† | MGP Ingredients, Inc | ||||
Investigators † |
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Information Provided By | Kansas State University | ||||
Verification Date | May 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |