Glycemic Index in Mitochondrial Disease
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ClinicalTrials.gov Identifier: NCT02284334 |
Recruitment Status :
Completed
First Posted : November 6, 2014
Last Update Posted : December 6, 2017
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Tracking Information | |||
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First Submitted Date | October 21, 2014 | ||
First Posted Date | November 6, 2014 | ||
Last Update Posted Date | December 6, 2017 | ||
Study Start Date | October 2014 | ||
Actual Primary Completion Date | October 2016 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
lactate area under the curve (AUC) for 3 hours after MMTT [ Time Frame: visit 1 (baseline, 0 months), visit 2 (around 1 month) ] within-subject change in lactate area under the curve (AUC) for 3 hours (low- vs. high- glycemic index)
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Original Primary Outcome Measures | Same as current | ||
Change History | Complete list of historical versions of study NCT02284334 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Glycemic Index in Mitochondrial Disease | ||
Official Title | Acute Effects of Dietary Glycemic Index on Lactate and Glucose Homeostasis in Individuals With Primary Mitochondrial Disease | ||
Brief Summary | The investigators are conducting a research study on nutrition in mitochondrial disease. The investigators are interested in the kind of carbohydrates that people eat. Carbohydrates are an important source of energy. Certain kinds of carbohydrates tend to raise blood sugar more in healthy people, and others tend to raise blood sugar less in healthy people. The investigators would like to know if by eating the "right" type of carbohydrate, people with mitochondrial disease can avoid high lactate levels, high blood sugar levels, and, later, low blood sugars. In this study, this question will be answered by finding out how people with mitochondrial disease respond to two different test meals containing different kinds of carbohydrates. Neither participants nor the investigators will know which kind of test meal participants are eating. |
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Detailed Description | This research study involves two study visits at CHOP, each around 6 to 8 hours long. The time the visit takes can depend on how long it takes to complete the study procedures listed. This can be different from person to person. The length of time between Visit #1 and Visit #2 will be between 2 weeks and 3 months. Overall study participation will not exceed 6 months. The study involves the following tests and procedures. These happen at each of the two visits:
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Study Type | Observational | ||
Study Design | Observational Model: Case-Crossover Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||
Biospecimen | Retention: Samples Without DNA Description: Blood samples obtained during MMTT.
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Sampling Method | Non-Probability Sample | ||
Study Population | patients with mitochondrial diseases, from existing observational cohort study and/or CHOP Genetics/Metabolism clinic | ||
Condition | Mitochondrial Diseases | ||
Intervention | Other: test meal
low- or high-glycemic index test meal, administered during mixed meal tolerance test
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Study Groups/Cohorts |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
18 | ||
Original Estimated Enrollment |
12 | ||
Actual Study Completion Date | October 2016 | ||
Actual Primary Completion Date | October 2016 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 7 Years to 65 Years (Child, Adult, Older Adult) | ||
Accepts Healthy Volunteers | No | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT02284334 | ||
Other Study ID Numbers | 14-011156 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | University of Pennsylvania | ||
Study Sponsor | University of Pennsylvania | ||
Collaborators | Children's Hospital of Philadelphia | ||
Investigators | Not Provided | ||
PRS Account | University of Pennsylvania | ||
Verification Date | December 2017 |