Glycemic Index in Mitochondrial Disease
Completed
Conditions studied: Mitochondrial Diseases
In brief
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.
Key facts
- Study ID
- NCT02284334
- Run by
- Children's Hospital of Philadelphia
- People needed
- 18
- Starts
- 2014-10-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2020-11-20
Who can join
Age: 7 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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