Mitochondrial DiseasesNCT02920671
Muscle OXPHOS and Nutrient Homeostasis
An observational study of Mitochondrial Diseases and Obesity, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Investigators are recruiting adults (men and women, ages 18 to 65 years, inclusive) with a confirmed genetic diagnosis of mitochondrial disease. Investigators are also recruiting both obese and normal-weight healthy volunteers (men and women, ages 18 to 65 years, inclusive) without a family history of mitochondrial… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Diseases, Obesity
- What is being tested?
- Tracer-enhanced oral glucose tolerance test (OGTT*), Muscle MRI and Dual energy x-ray absorptiometry (DXA)
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2017to 28 Aug 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll three groups of individuals (mitochondrial disease, obese, normal weight).
Who may be able to join
- Indvidiuals who meet all of the following criteria are eligible for participation in the study:
- Male and female patients age 18 to 65 years of age.
- Ability to provide written informed consent.
- Cognitively and medically stable and able to comply with the procedures of the study protocol.
- For individuals with mitochondrial disease:
- Clinical history consistent with the diagnosis of mitochondrial disease, and molecular genetic diagnosis. To ensure consistency with other trials performed in mitochondrial disease, investigators will also ensure that participants meet the same set of previously published criteria. These include clinical features consistent with primary mitochondrial disease and molecular genetic proof of a pathogenic mutation in mtDNA or nDNA in a gene known to be associated with dysfunction of complexes I-V of the respiratory chain. Specifically, eligible participants must have defined mtDNA or nDNA mutations affecting subunits or assembly of these complexes that are associated with known clinical/pathological features, such as chronic progressive external ophthalmoplegia (CPEO), Kearns-Sayre, mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), mitochondrial encephalopathy and ragged red fibers (MERRF), neuropathy, ataxia and retinitis pigmentosa (NARP) or Leigh syndrome (45). Investigators will explicitly include individuals with Friedreich's Ataxia (46), a mutation in the mitochondrial protein frataxin, and those with mutations in respiratory chain complex II protein, succinate dehydrogenase (SDH).
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- For normal weight participants:
- BMI < 25 kg/m2. These will be matched with subjects with mitochondrial disease by age, sex, estrogen status (women), and usual self-reported physical activity (as either sedentary or not, i.e., for sedentary, less than 30 minutes of moderate physical activity 5 days per week, or vigorous physical activity for 20 minutes 3 days per week).
- For obese participants:
- BMI > 30 kg/m2. These will be matched with subjects with mitochondrial disease by age, sex, estrogen status (women), and usual self-reported physical activity (as either sedentary or not, i.e., for sedentary, less than 30 minutes of moderate physical activity 5 days per week, or vigorous physical activity for 20 minutes 3 days per week).
Who cannot join
- For all study groups (i.e., mitochondrial disease, normal weight, obese):
- Diabetes (HgbA1c > 6.4%) and/or taking insulin or other anti-diabetic drug therapy within the 4 weeks prior to enrollment.
- Use of any lipid-lowering medication (excluding nutritional supplements) within the 4 weeks prior to enrollment.
- Any contraindication to MRI study (e.g., implanted non-compatible device, pacemaker, known claustrophobia).
- Kidney disease. Estimated glomerular filtration rate < 60 ml/min/1.73 m2 (calculated using the subject's measure serum creatinine and the Modification of Diet in Renal Disease [MDRD] study estimation formula).
- Liver disease. Persistent elevation of liver function tests at the time of study entry. Persistent SGOT (AST), SGPT (ALT), Alk Phos or total bilirubin, with values > 3 times normal upper limits, will exclude a subject from study participation.
Show all 29Show fewer
- Severe co-existing cardiac disease, characterized by any one of these self-reported conditions:
- recent myocardial infarction (within the past 6 months).
- evidence of ischemia on functional cardiac exam within the last year
- left ventricular ejection fraction < 30%.
- Acute or chronic pancreatitis.
- Receiving treatment for a medical condition requiring chronic use of systemic (oral or parenteral steroids, except for the use of < 5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only.
- Anemia (baseline hemoglobin concentration < 11 g/dl in women and <12 g/dl in men), lymphopenia, (< 1,000/µL), neutropenia (< 1,500/µL), or thrombocytopenia (platelets < 100,000/µL).
- Any known coagulopathy (including Factor V deficiency) or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) (low-dose aspirin treatment is allowed) or patients with an INR > 1.5.
- For female participants: Positive pregnancy test.
- Known active alcohol or substance abuse, including known tobacco use.
- Use of any investigational agents within 4 weeks of enrollment.
- Inability to fast comfortably for 10 hours (i.e., overnight).
- Individuals who have a pacemaker, metal implants, claustrophobia, have worked around a metal grinder or a construction site, or that have known medical conditions which can be exacerbated by stress such as anxiety or panic attacks. Inability to lie flat in the MRI scanner for 90 minutes is also an exclusion criterion.
- In addition, specific exclusion criteria for undergoing MRI scanning include:
- ANY intra-luminal implant, filter, stent or valve replacement
- ANY type of life assist device, pump, or prosthetic
- ANY vascular clip or clamp
- ANY surgically placed clips or clamps or bands on visceral organs
- ANY intracranial implants of any type other than dental fillings
- ANY non-removable piercings, jewelry, or medicinal patch
- ANY personal history of intraocular injury or fragment in or around the orbit that cannot be cleared through radiologic examination.
- ANY personal history of bullet, shrapnel, or stabbing wounds that cannot be cleared through radiologic evaluation.
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19004
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Skeletal Muscle Oxidative Phosphorylation Capacity and Nutrient Homeostasis in Individuals With Primary (Genetic) and Secondary (Obesity-related) Mitochondrial Impairment as Compared to Healthy, Normal-weight Individuals
Investigators are recruiting adults (men and women, ages 18 to 65 years, inclusive) with a confirmed genetic diagnosis of mitochondrial disease. Investigators are also recruiting both obese and normal-weight healthy volunteers (men and women, ages 18 to 65 years, inclusive) without a family history of mitochondrial disease to compare to affected individuals.
The study involves non-invasive MRI methods and glucose tests to focus on the relationship between mitochondrial disease, obesity, and the risk of diabetes. All study visit procedures will be completed within 2 days, which includes an overnight stay at the Hospital of the University of Pennsylvania. There are no study medications or sedations, and participants will be continually monitored during minimally-invasive procedures (e.g., blood draws).
Read more
All participants will be able to receive compensation. Furthermore, it may be possible to provide reimbursement for travel, lodging, and meals for individuals with mitochondrial disease.
Investigators hope that this research will contribute to the current knowledge of mitochondrial disease and that it will improve diagnostic and treatment approaches.
Read the detailed description
Although obesity is a significant public health problem, why obesity leads to diabetes in some individuals but not others is poorly understood. Mitochondrial impairment, particularly in skeletal muscle with its high energy requirement, has been implicated in the pathogenesis of obesity-related insulin resistance. In addition, individuals with genetic disorders affecting mitochondrial function are at increased risk of diabetes. The proposed studies will investigate the association between skeletal muscle oxidative phosphorylation capacity (OXPHOS), which is a dimension of mitochondrial function, and glucose and lipid homeostasis in (i) individuals with genetic disorders of muscle mitochondrial function as compared to (ii) non-obese adults and (iii) otherwise healthy obese adults.
During a single 2-day, 1-night study visit, investigators will use innovative, non-invasive magnetic resonance imaging-based methods of estimating skeletal muscle oxidative phosphorylation capacity, including post-exercise chemical exchange saturation transfer (CrCEST) recovery and 31-Phosphorus (31P) magnetic resonance spectroscopy (MRS) and muscle lipid content, including 1H magnetic resonance spectroscopy (MRS) and 3-point Dixon techniques, in conjunction with a tracer-enhanced oral glucose tolerance test (OGTT*) to measure overall insulin sensitivity and the selective effect of insulin on glucose disposal (Rd). The percentage suppression of endogenous glucose production by the oral glucose load (% suppression of Ra of endogenous glucose) will also be assessed. Infusion of a glycerol tracer permits assessment of lipolysis in both the fasting state, and also after the oral glucose load, such that the percentage suppression of lipolysis by the oral glucose load can also be calculated (% suppression of Ra of glycerol). In addition, the insulin and c-peptide minimal models will also be used to model pancreatic β-cell responsiveness to the oral glucose load and hepatic insulin extraction.
- Conditions
- Mitochondrial Diseases, Obesity
- Being tested
- Tracer-enhanced oral glucose tolerance test (OGTT*), Muscle MRI, Dual energy x-ray absorptiometry (DXA), Questionnaires
- Medical subject headings
- Mitochondrial Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracer-enhanced oral glucose tolerance test (OGTT*)Other
Oral glucose tolerance test with stable isotope tracers will be administered. Resting energy expenditure and respiratory quotient will be evaluated during this test using indirect calorimetry.
Muscle MRIOther
Non-invasive muscle MRI will be performed to evaluated metabolic capacity.
Dual energy x-ray absorptiometry (DXA)Other
DXA will be performed to evaluate body composition.
QuestionnairesOther
Questionnaires will be used to evaluate participants' health and habits.
| Study group | Role | What they receive |
|---|---|---|
| Mitochondrial Disease | Clinical history consistent with the diagnosis of mitochondrial disease, and molecular genetic diagnosis. Receives: Other: Tracer-enhanced oral glucose tolerance test (OGTT*); Other: Muscle MRI; Other: Dual energy x-ray absorptiometry (DXA); Other: Questionnaires | |
| Obese | BMI > 30 kg/m2. These will be matched with subjects with mitochondrial disease by age, sex, estrogen status (women), and usual self-reported physical activity. Receives: Other: Tracer-enhanced oral glucose tolerance test (OGTT*); Other: Muscle MRI; Other: Dual energy x-ray absorptiometry (DXA); Other: Questionnaires | |
| Normal Weight & Overweight | BMI 18.5 - < 30 kg/m2. These will be matched with subjects with mitochondrial disease by age, sex, estrogen status (women), and usual self-reported physical activity. Receives: Other: Tracer-enhanced oral glucose tolerance test (OGTT*); Other: Muscle MRI; Other: Dual energy x-ray absorptiometry (DXA); Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose rate of disposal (glucose Rd) during OGTT*
The primary outcome for the present study will be glucose rate of disposal (Rd) during the OGTT*
Measured: 1 day
Secondary outcomes (7)
Exogenous rate of glucose appearance (exogenous glucose Ra) during OGTT*
Measured: 1 day
Endogenous rate of glucose appearance (endogenous glucose Ra) during OGTT*
Measured: 1 day
Endogenous rate of glycerol appearance (endogenous glycerol Ra) during OGTT*
Measured: 1 day
Post-exercise exponential time constant for decline in CrCEST (skeletal muscle MRI)
Measured: 1 day
Resting CrCEST (skeletal muscle MRI)
Measured: 1 day
Muscle fat content (skeletal muscle MRI)
Measured: 1 day
Blood glucose variability (continuous glucose monitoring)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start14 Feb 2017
- Primary completion30 Mar 2019
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shana McCormack, MD, MTR, Principal investigator, University of Pennsylvania & Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920671
- Sponsor's protocol ID
- 825558
- Status last verified
- Aug 2024
- First submitted
- 27 Sep 2016
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Tamaroff J, Nguyen S, Wilson NE, Stefanovski D, Xiao R, Scattergood T, Capiola C, Schur GM, Dunn J, Dedio A, Wade K, Shah H, Sharma R, Mootha VK, Kelly A, Lin KY, Lynch DR, Reddy R, Rickels MR, McCormack SE. Insulin Sensitivity and Insulin Secretion in Adults With Friedreich's Ataxia: The Role of Skeletal Muscle. J Clin Endocrinol Metab. 2025 Jan 21;110(2):317-333. doi: 10.1210/clinem/dgae545.
PubMed 39109797
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Oxidative Phosphorylation Capacity and Nutrient Homeostasis in Individuals With Primary (Genetic) and Secondary (Obesity-related) Mitochondrial Impairment as Compared to Healthy, Normal-weight Individuals
- ClinicalTrials.gov ID
- NCT02920671
- Acronym / sponsor ID
- 825558
- Conditions
- Mitochondrial Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 30 Sep 2016 (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.
Investigators are recruiting adults (men and women, ages 18 to 65 years, inclusive) with a confirmed genetic diagnosis of mitochondrial disease. Investigators are also recruiting both obese and normal-weight healthy volunteers (men and women, ages 18 to 65 years, inclusive) without a family history of mitochondrial disease to compare to affected individuals.
The study involves non-invasive MRI methods and glucose tests to focus on the relationship between mitochondrial disease, obesity, and the risk of diabetes. All study visit procedures will be completed within 2 days, which includes an overnight stay at the Hospital of the University of Pennsylvania. There are no study medications or sedations, and participants will be continually monitored during minimally-invasive procedures (e.g., blood draws).
All participants will be able to receive compensation. Furthermore, it may be possible to provide reimbursement for travel, lodging, and meals for individuals with mitochondrial disease.
Investigators hope that this research will contribute to the current knowledge of mitochondrial disease and that it will improve diagnostic and treatment approaches.
Detailed description
Although obesity is a significant public health problem, why obesity leads to diabetes in some individuals but not others is poorly understood. Mitochondrial impairment, particularly in skeletal muscle with its high energy requirement, has been implicated in the pathogenesis of obesity-related insulin resistance. In addition, individuals with genetic disorders affecting mitochondrial function are at increased risk of diabetes. The proposed studies will investigate the association between skeletal muscle oxidative phosphorylation capacity (OXPHOS), which is a dimension of mitochondrial function, and glucose and lipid homeostasis in (i) individuals with genetic disorders of muscle mitochondrial function as compared to (ii) non-obese adults and (iii) otherwise healthy obese adults.
During a single 2-day, 1-night study visit, investigators will use innovative, non-invasive magnetic resonance imaging-based methods of estimating skeletal muscle oxidative phosphorylation capacity, including post-exercise chemical exchange saturation transfer (CrCEST) recovery and 31-Phosphorus (31P) magnetic resonance spectroscopy (MRS) and muscle lipid content, including 1H magnetic resonance spectroscopy (MRS) and 3-point Dixon techniques, in conjunction with a tracer-enhanced oral glucose tolerance test (OGTT*) to measure overall insulin sensitivity and the selective effect of insulin on glucose disposal (Rd). The percentage suppression of endogenous glucose production by the oral glucose load (% suppression of Ra of endogenous glucose) will also be assessed. Infusion of a glycerol tracer permits assessment of lipolysis in both the fasting state, and also after the oral glucose load, such that the percentage suppression of lipolysis by the oral glucose load can also be calculated (% suppression of Ra of glycerol). In addition, the insulin and c-peptide minimal models will also be used to model pancreatic β-cell responsiveness to the oral glucose load and hepatic insulin extraction.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mitochondrial Disease | – | Other: Tracer-enhanced oral glucose tolerance test (OGTT*), Other: Muscle MRI, Other: Dual energy x-ray absorptiometry (DXA), Other: QuestionnairesClinical history consistent with the diagnosis of mitochondrial disease, and molecular genetic diagnosis. |
| Obese | – | Other: Tracer-enhanced oral glucose tolerance test (OGTT*), Other: Muscle MRI, Other: Dual energy x-ray absorptiometry (DXA), Other: QuestionnairesBMI > 30 kg/m2. These will be matched with subjects with mitochondrial disease by age, sex, estrogen status (women), and usual self-reported physical activity. |
| Normal Weight & Overweight | – | Other: Tracer-enhanced oral glucose tolerance test (OGTT*), Other: Muscle MRI, Other: Dual energy x-ray absorptiometry (DXA), Other: QuestionnairesBMI 18.5 - < 30 kg/m2. These will be matched with subjects with mitochondrial disease by age, sex, estrogen status (women), and usual self-reported physical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll three groups of individuals (mitochondrial disease, obese, normal weight).
Key inclusion criteria (10 listed)
- Indvidiuals who meet all of the following criteria are eligible for participation in the study:
- Male and female patients age 18 to 65 years of age.
- Ability to provide written informed consent.
- Cognitively and medically stable and able to comply with the procedures of the study protocol.
- Clinical history consistent with the diagnosis of mitochondrial disease, and molecular genetic diagnosis. To ensure consistency with other trials performed in mitochondrial disease, investigators will also ensure that participants meet the same set of previously published criteria. These include clinical features consistent with primary mitochondrial disease and molecular genetic proof of a pathogenic mutation in mtDNA or nDNA in a gene known to be associated with dysfunction of complexes I-V of the respiratory chain. Specifically, eligible participants must have defined mtDNA or nDNA mutations affecting subunits or assembly of these complexes that are associated with known clinical/pathological features, such as chronic progressive external ophthalmoplegia (CPEO), Kearns-Sayre, mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), mitochondrial encephalopathy and ragged red fibers (MERRF), neuropathy, ataxia and retinitis pigmentosa (NARP) or Leigh syndrome (45). Investigators will explicitly include individuals with Friedreich's Ataxia (46), a mutation in the mitochondrial protein frataxin, and those with mutations in respiratory chain complex II protein, succinate dehydrogenase (SDH).
Key exclusion criteria (29 listed)
- Diabetes (HgbA1c > 6.4%) and/or taking insulin or other anti-diabetic drug therapy within the 4 weeks prior to enrollment.
- Use of any lipid-lowering medication (excluding nutritional supplements) within the 4 weeks prior to enrollment.
- Any contraindication to MRI study (e.g., implanted non-compatible device, pacemaker, known claustrophobia).
- Kidney disease. Estimated glomerular filtration rate < 60 ml/min/1.73 m2 (calculated using the subject's measure serum creatinine and the Modification of Diet in Renal Disease [MDRD] study estimation formula).
- Liver disease. Persistent elevation of liver function tests at the time of study entry. Persistent SGOT (AST), SGPT (ALT), Alk Phos or total bilirubin, with values > 3 times normal upper limits, will exclude a subject from study participation.
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 |
|---|---|---|
| Tracer-enhanced oral glucose tolerance test (OGTT*)Oral glucose tolerance test with stable isotope tracers will be administered. Resting energy expenditure and respiratory quotient will be evaluated during this test using indirect calorimetry. | Other | Mitochondrial Disease, Normal Weight & Overweight, Obese |
| Muscle MRINon-invasive muscle MRI will be performed to evaluated metabolic capacity. | Other | Mitochondrial Disease, Normal Weight & Overweight, Obese |
| Dual energy x-ray absorptiometry (DXA)DXA will be performed to evaluate body composition. | Other | Mitochondrial Disease, Normal Weight & Overweight, Obese |
| QuestionnairesQuestionnaires will be used to evaluate participants' health and habits. | Other | Mitochondrial Disease, Normal Weight & Overweight, Obese |
Primary outcome
Glucose rate of disposal (glucose Rd) during OGTT*
Time frame: 1 day
The primary outcome for the present study will be glucose rate of disposal (Rd) during the OGTT*
7 secondary outcomes
Exogenous rate of glucose appearance (exogenous glucose Ra) during OGTT*
Time frame: 1 day
Endogenous rate of glucose appearance (endogenous glucose Ra) during OGTT*
Time frame: 1 day
Endogenous rate of glycerol appearance (endogenous glycerol Ra) during OGTT*
Time frame: 1 day
Post-exercise exponential time constant for decline in CrCEST (skeletal muscle MRI)
Time frame: 1 day
Resting CrCEST (skeletal muscle MRI)
Time frame: 1 day
Muscle fat content (skeletal muscle MRI)
Time frame: 1 day
Blood glucose variability (continuous glucose monitoring)
Time frame: 14 days
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 3 Sep 2024.
- Results publication: PubMed 39109797Tamaroff J, Nguyen S, Wilson NE, Stefanovski D, Xiao R, Scattergood T, Capiola C, Schur GM, Dunn J, Dedio A, Wade K, Shah H, Sharma R, Mootha VK, Kelly A, Lin KY, Lynch DR, Reddy R, Rickels MR, McCormack SE. Insulin Sensitivity and Insulin Secretion in Adults With Friedreich's Ataxia: The Role of Skeletal Muscle. J Clin Endocrinol Metab. 2025 Jan 21;110(2):317-333. doi: 10.1210/clinem/dgae545.
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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.
Shana McCormack, MD, MTR principal investigator
University of Pennsylvania & Children's Hospital of Philadelphia
2 sites 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 and Obesity, run by University of Pennsylvania at 2 sites 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 10 inclusion and 29 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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Glucose rate of disposal (glucose Rd) during OGTT* (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920671, which also lists 1 linked publication.
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 3 Sep 2024.