Mitochondrial DiseasesNCT02284334
Glycemic Index in Mitochondrial Disease
An observational study of Mitochondrial Diseases, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Mitochondrial Diseases
- What is being tested?
- test meal
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with mitochondrial diseases, from existing observational cohort study and/or CHOP Genetics/Metabolism clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Acute Effects of Dietary Glycemic Index on Lactate and Glucose Homeostasis in Individuals With Primary Mitochondrial Disease
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.
Read the 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.
- Conditions
- Mitochondrial Diseases
- Being tested
- test meal
- Keywords
- mitochondrial diseases, nutrition, glycemic index
- Medical subject headings
- Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test mealOther
low- or high-glycemic index test meal, administered during mixed meal tolerance test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: visit 1 (baseline, 0 months), visit 2 (around 1 month)
Secondary outcomes (4)
hypoglycemia (< 70 mg/dL) post-MMTT
Measured: visit 1 (baseline, 0 months), visit 2 (around 1 month)
glucose area under the curve (AUC) for 3 hours after MMTT
within-subject change in glucose area under the curve (AUC) for 3 hours (low- vs. high- glycemic index)
Measured: visit 1 (baseline, 0 months), visit 2 (around 1 month)
insulin area under the curve (AUC) for 3 hours after MMTT
within-subject change in insulin area under the curve (AUC) for 3 hours (low- vs. high- glycemic index)
Measured: visit 1 (baseline, 0 months), visit 2 (around 1 month)
combined index of attention (CPT-III) during MMTT
Measured: visit 1 (baseline, 0 months), visit 2 (around 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284334
- Sponsor's protocol ID
- 14-011156
- Status last verified
- Nov 2020
- First submitted
- 21 Oct 2014
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Dietary Glycemic Index on Lactate and Glucose Homeostasis in Individuals With Primary Mitochondrial Disease
- ClinicalTrials.gov ID
- NCT02284334
- Acronym / sponsor ID
- 14-011156
- Conditions
- Mitochondrial Diseases
- Keywords
- mitochondrial diseases, nutrition, glycemic index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low GI-High GI | – | Other: test mealTwo 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 |
| High GI-Low GI | – | Other: test mealTwo 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 |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with mitochondrial diseases, from existing observational cohort study and/or CHOP Genetics/Metabolism clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test meallow- or high-glycemic index test meal, administered during mixed meal tolerance test | Other | High GI-Low GI, Low GI-High GI |
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)
4 secondary outcomes
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)
insulin area under the curve (AUC) for 3 hours after MMTT
Time frame: visit 1 (baseline, 0 months), visit 2 (around 1 month)
combined index of attention (CPT-III) during MMTT
Time frame: visit 1 (baseline, 0 months), visit 2 (around 1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitochondrial Diseases, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lactate area under the curve (AUC) for 3 hours after MMTT (time frame: visit 1 (baseline, 0 months), visit 2 (around 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.