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Glycemic Index in Mitochondrial Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284334
First Posted: November 6, 2014
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose

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.


Condition Intervention
Mitochondrial Diseases Other: test meal

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Acute Effects of Dietary Glycemic Index on Lactate and Glucose Homeostasis in Individuals With Primary Mitochondrial Disease

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

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)


Secondary Outcome Measures:
  • 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) ]

Biospecimen Retention:   Samples Without DNA
Blood samples obtained during MMTT.

Enrollment: 18
Study Start Date: October 2014
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Low GI-High GI

Two study visits are separate by around one month.

For this arm, test meal (Visit 1): low-glycemic index; test meal (Visit 2): high-glycemic index

Other: test meal
low- or high-glycemic index test meal, administered during mixed meal tolerance test
High GI-Low GI

Two study visits are separate by around one month.

For this arm, test meal (Visit 1): high-glycemic index; test meal (Visit 2): low-glycemic index

Other: test meal
low- or high-glycemic index test meal, administered during mixed meal tolerance test

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:

  • 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 physical function and well-being. These are designed for people with mitochondrial disease (or for parents of children with mitochondrial disease). They should take around 20 minutes.
  • Pre-Test Fast: The participant will not be able to eat or drink anything except plain, unflavored water (i.e., you will "fast") for at least 4 hours before the mixed-meal tolerance test starts. S/he will get the test meal at that time. S/he will receive a recommendation when the visit is scheduled when to begin fasting. This recommendation is designed for no more than 10 hours of fasting, or the participant's longest usual overnight fast, whichever is shorter.
  • Mixed Meal Tolerance Test (MMTT): The test includes placement of an intravenous (IV) line in the participant's arm/hand to make taking the blood samples easier. With the IV in place, the participant will not need to be stuck again for any further blood draws, unless the IV stops working. If s/he prefers, a numbing cream can be placed on your skin for about 45 minutes before this test to numb the area. Once the IV is in place, the participant will receive a test "shake". S/he will have about 30 minutes to finish the shake. Over the next 4 hours, blood will be drawn every 30 minutes from the IV line. The total amount of blood drawn for the MMTT will be a little less than 2 tablespoons.
  • Cognitive Testing: Two times during the MMTT participants will be asked to perform some testing on a computer (for example, pressing a button as soon as you see a symbol appear). Each test will take around 14 minutes and tests things like attention and reaction time. We will show you how these tests work before the MMTT.
  • Dual Energy X-ray Absorptiometry (DXA) Scan: A special x-ray of the body called a DXA scan will be done to measure the amount of fat and lean (non-fat) tissue in the participant's body. During the DXA scan, the participant will be asked to lie flat on your back on a table as the scanning machine moves above the participant's body. The DXA scan is like an X-ray, and takes about 5-10 minutes. This test is painless and does not involve any needles.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with mitochondrial diseases, from existing observational cohort study and/or CHOP Genetics/Metabolism clinic
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284334


Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02284334     History of Changes
Other Study ID Numbers: 14-011156
First Submitted: October 21, 2014
First Posted: November 6, 2014
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by University of Pennsylvania:
mitochondrial diseases
nutrition
glycemic index

Additional relevant MeSH terms:
Mitochondrial Diseases
Metabolic Diseases