Status:
COMPLETED
Glycemic Index in Mitochondrial Disease
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Mitochondrial Diseases
Eligibility:
All Genders
7-65 years
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 s...
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 diff...
Eligibility Criteria
Inclusion
- Weight \> 15 kg
- Girls ≥ 11 years of age and/or who have achieved menarche must have a negative urine pregnancy test.
- Genetic and/or biochemical diagnosis of mitochondrial disease.
- Eat meals by mouth during the day.
Exclusion
- Diabetes requiring insulin.
- Receive daytime total parenteral nutrition (TPN) and/or continuous enteral feedings.
- Prescribed dietary contraindication to mixed meal tolerance testing, e.g., ketogenic diet.
- Any investigational drug use within 30 days prior to enrollment.
- Pregnant or lactating females.
- Persons unable to fast for at least 4 hours.
- Persons who may be allergic to the test meals (shakes).
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-adherent to study schedules or procedures.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02284334
Start Date
October 1 2014
End Date
October 1 2016
Last Update
November 20 2020
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104