Glycemic Index in Mitochondrial Disease

NCT02284334 | Completed

• 1 other identifier: 14-011156
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Diseases

Keywords

mitochondrial diseases; nutrition; glycemic index

Outcome Measures

Primary Outcomes (1)

• lactate area under the curve (AUC) for 3 hours after MMTT

  within-subject change in lactate area under the curve (AUC) for 3 hours (low- vs. high- glycemic index)

  visit 1 (baseline, 0 months), visit 2 (around 1 month)

Secondary Outcomes (4)

• hypoglycemia (< 70 mg/dL) post-MMTT

  visit 1 (baseline, 0 months), visit 2 (around 1 month)

• glucose area under the curve (AUC) for 3 hours after MMTT

  visit 1 (baseline, 0 months), visit 2 (around 1 month)

• insulin area under the curve (AUC) for 3 hours after MMTT

  visit 1 (baseline, 0 months), visit 2 (around 1 month)

• combined index of attention (CPT-III) during MMTT

  visit 1 (baseline, 0 months), visit 2 (around 1 month)

Study Arms (2)

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

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

Interventions

test meal OTHER

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

High GI-Low GI; Low GI-High GI

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with mitochondrial diseases, from existing observational cohort study and/or CHOP Genetics/Metabolism clinic

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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples obtained during MMTT.

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 6, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

US (1)