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Trial record 9 of 760 for:    Area Under Curve AND meal

Glycemic Index in Mitochondrial Disease

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.
 
ClinicalTrials.gov Identifier: NCT02284334
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
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
 (submitted: November 4, 2014)
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 Measures Same as current
Change History Complete list of historical versions of study NCT02284334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 4, 2014)
  • 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 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.

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.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples obtained during MMTT.
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
Study Groups/Cohorts
  • 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

    Intervention: Other: test meal
  • 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

    Intervention: Other: test meal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 4, 2016)
18
Original Estimated Enrollment
 (submitted: November 4, 2014)
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:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
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