Clinical Trial: Glycemic Index in Mitochondrial Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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.


Detailed Summary:

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:

  • Interviews: A team member will take the participant's medical history, along with a listing of any medications s/he is taking. Throughout the study the participant will be asked to report if s/he thinks that anything bad has happened as a result of the study.
  • 3-day diet record: The investigator will collect the record the participant made of everything s/he ate for the 3 days before the study visit.
  • Physical Examination: The investigators will measure the participant's weight, height, blood pressure, heart rate and respiratory rate, and waist circumference. If the participant is under age 21 years, a pediatric endocrinologist will check how far s/he is along in puberty. For both boys and girls, pubic hair growth will be checked. For girls, breast development will be checked. For boys, testicular development will be checked. This examination will take approximately 2 minutes and will be done in a private room.
  • Pregnancy Test (female subjects): If a female participant is eleven years old or older and/or has already started having periods, she will be asked to take a pregnancy test before starting this study.
  • Questionnaires: Investigators will ask the participant to fill out questionnaires on his/her
    Sponsor: University of Pennsylvania

    Current Primary Outcome: 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)


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • hypoglycemia (< 70 mg/dL) post-MMTT [ Time Frame: visit 1 (baseline, 0 months), visit 2 (around 1 month) ]
    • glucose 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 glucose area under the curve (AUC) for 3 hours (low- vs. high- glycemic index)
    • insulin 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 insulin area under the curve (AUC) for 3 hours (low- vs. high- glycemic index)
    • combined index of attention (CPT-III) during MMTT [ Time Frame: visit 1 (baseline, 0 months), visit 2 (around 1 month) ]


    Original Secondary Outcome: Same as current

    Information By: University of Pennsylvania

    Dates:
    Date Received: October 21, 2014
    Date Started: October 2014
    Date Completion:
    Last Updated: November 4, 2016
    Last Verified: November 2016