Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
26 participants
INTERVENTIONAL
2014-05-31
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mitochondrial Dysfunction in Diabetes
NCT01724502
Mitochondrial Impairment in Muscle Insulin Resistance
NCT00222924
Mitochondrial Dysfunction in Type 2 Diabetes Mellitus and Capacity for Fat Oxidation During Exercise
NCT00382473
Beneficial Effects of Exercise and Healthy Diets on Muscle and Adipose Tissue
NCT01793896
Molecular Mechanisms of Exercise Benefits to Insulin Resistant People
NCT04158375
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lean Controls
Lean controls will have BMI of 25 or less, gender specific normal body fat, and not be taking any medication that affects glucose metabolism.
Interventions include OGTT, Clamp, VO2 Max, Exercise Test and Muscle Biopsy
Pre-study dietary and exercise instruction.
All subjects will be instructed to continue their normal diet during the three days prior to study, to not consume alcohol the day before study, and to not engage in exercise for 48 hours before all studies.
Screening examination and oral glucose tolerance test
All subjects will have screening exam and OGTT at the Clinical Studies Infusion Unit at Mayo Clinic in Arizona at 7-8 am after having eaten nothing after 10 PM the night before, and have a screening examination and 75 g OGTT, as described
Euglycemic clamp
On a separate day, subjects will have a two-hour euglycemic clamp ((80 mU insulin/(m2.min)) at the Clinical Studies Unit at Mayo Clinic Arizona at 7-8 am after an overnight fast. A muscle biopsy will be taken before the insulin infusion, to serve as the resting biopsy (3). Biopsy specimens (150-300 mg) will be frozen immediately in liquid nitrogen and stored in liquid nitrogen until they are processed
VO2max.
VO2max.
Acute exercise bout
The single acute exercise bout will be performed as described (3). It consists of 4 sets of 12 min each (8 min @ 70% VO2max, 2 min @ 90%, 2 min rest, repeat X 4). Biopsies are taken 30 min and 24 hr after end of exercise. Resting biopsies are taken on the glucose clamp day
Percutaneous needle muscle biopsies
Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing. We routinely obtain 150-300 mg muscle (wet weight), which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research. Muscle will be processed either for isolation of mRNA/microRNA or protein, as described (2, 3, 12).
Obese, Non-diabetic
Obese nondiabetics will have a BMI between 30-50 and not be taking any medication that affects glucose metabolism.
Interventions include OGTT, Clamp, VO2 Max, Exercise Test and Muscle Biopsy
Pre-study dietary and exercise instruction.
All subjects will be instructed to continue their normal diet during the three days prior to study, to not consume alcohol the day before study, and to not engage in exercise for 48 hours before all studies.
Screening examination and oral glucose tolerance test
All subjects will have screening exam and OGTT at the Clinical Studies Infusion Unit at Mayo Clinic in Arizona at 7-8 am after having eaten nothing after 10 PM the night before, and have a screening examination and 75 g OGTT, as described
Euglycemic clamp
On a separate day, subjects will have a two-hour euglycemic clamp ((80 mU insulin/(m2.min)) at the Clinical Studies Unit at Mayo Clinic Arizona at 7-8 am after an overnight fast. A muscle biopsy will be taken before the insulin infusion, to serve as the resting biopsy (3). Biopsy specimens (150-300 mg) will be frozen immediately in liquid nitrogen and stored in liquid nitrogen until they are processed
VO2max.
VO2max.
Acute exercise bout
The single acute exercise bout will be performed as described (3). It consists of 4 sets of 12 min each (8 min @ 70% VO2max, 2 min @ 90%, 2 min rest, repeat X 4). Biopsies are taken 30 min and 24 hr after end of exercise. Resting biopsies are taken on the glucose clamp day
Percutaneous needle muscle biopsies
Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing. We routinely obtain 150-300 mg muscle (wet weight), which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research. Muscle will be processed either for isolation of mRNA/microRNA or protein, as described (2, 3, 12).
Diabetic
Diabetic patients will have a BMI between 30-50. We will recruit patients with mild or newly diagnosed type 2 diabetes who are treated with diet, sulfonylureas, or other drugs working through enhanced insulin secretion. Patients taking metformin or TZDs will not be recruited due to the effects of those drugs on insulin action.
Interventions include OGTT, Clamp, VO2 Max, Exercise Test and Muscle Biopsy
Pre-study dietary and exercise instruction.
All subjects will be instructed to continue their normal diet during the three days prior to study, to not consume alcohol the day before study, and to not engage in exercise for 48 hours before all studies.
Screening examination and oral glucose tolerance test
All subjects will have screening exam and OGTT at the Clinical Studies Infusion Unit at Mayo Clinic in Arizona at 7-8 am after having eaten nothing after 10 PM the night before, and have a screening examination and 75 g OGTT, as described
Euglycemic clamp
On a separate day, subjects will have a two-hour euglycemic clamp ((80 mU insulin/(m2.min)) at the Clinical Studies Unit at Mayo Clinic Arizona at 7-8 am after an overnight fast. A muscle biopsy will be taken before the insulin infusion, to serve as the resting biopsy (3). Biopsy specimens (150-300 mg) will be frozen immediately in liquid nitrogen and stored in liquid nitrogen until they are processed
VO2max.
VO2max.
Acute exercise bout
The single acute exercise bout will be performed as described (3). It consists of 4 sets of 12 min each (8 min @ 70% VO2max, 2 min @ 90%, 2 min rest, repeat X 4). Biopsies are taken 30 min and 24 hr after end of exercise. Resting biopsies are taken on the glucose clamp day
Percutaneous needle muscle biopsies
Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing. We routinely obtain 150-300 mg muscle (wet weight), which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research. Muscle will be processed either for isolation of mRNA/microRNA or protein, as described (2, 3, 12).
Non-diabetic
Patients will be nondiabetic, although we will include patients with impaired glucose tolerance. Patients will meet criteria for treatment with fibrates to lower plasma triglyceride concentrations (triglyceride\>300 mg/dl for nondiabetics, 250 mg/dl for patients with impaired glucose tolerance). We will aim at recruiting equal numbers of men and women. All participants will be between the ages of 30 and 59. Patients will have a BMI of 25-50 and not be taking any other medication that affects glucose metabolism. All participants will be sedentary (not reporting more than 10 minutes per day of light to vigorous leisure time physical activity.
Interventions include OGTT, Clamp, VO2 Max, Exercise Test and Muscle Biopsy
Pre-study dietary and exercise instruction.
All subjects will be instructed to continue their normal diet during the three days prior to study, to not consume alcohol the day before study, and to not engage in exercise for 48 hours before all studies.
Screening examination and oral glucose tolerance test
All subjects will have screening exam and OGTT at the Clinical Studies Infusion Unit at Mayo Clinic in Arizona at 7-8 am after having eaten nothing after 10 PM the night before, and have a screening examination and 75 g OGTT, as described
Euglycemic clamp
On a separate day, subjects will have a two-hour euglycemic clamp ((80 mU insulin/(m2.min)) at the Clinical Studies Unit at Mayo Clinic Arizona at 7-8 am after an overnight fast. A muscle biopsy will be taken before the insulin infusion, to serve as the resting biopsy (3). Biopsy specimens (150-300 mg) will be frozen immediately in liquid nitrogen and stored in liquid nitrogen until they are processed
VO2max.
VO2max.
Acute exercise bout
The single acute exercise bout will be performed as described (3). It consists of 4 sets of 12 min each (8 min @ 70% VO2max, 2 min @ 90%, 2 min rest, repeat X 4). Biopsies are taken 30 min and 24 hr after end of exercise. Resting biopsies are taken on the glucose clamp day
Percutaneous needle muscle biopsies
Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing. We routinely obtain 150-300 mg muscle (wet weight), which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research. Muscle will be processed either for isolation of mRNA/microRNA or protein, as described (2, 3, 12).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pre-study dietary and exercise instruction.
All subjects will be instructed to continue their normal diet during the three days prior to study, to not consume alcohol the day before study, and to not engage in exercise for 48 hours before all studies.
Screening examination and oral glucose tolerance test
All subjects will have screening exam and OGTT at the Clinical Studies Infusion Unit at Mayo Clinic in Arizona at 7-8 am after having eaten nothing after 10 PM the night before, and have a screening examination and 75 g OGTT, as described
Euglycemic clamp
On a separate day, subjects will have a two-hour euglycemic clamp ((80 mU insulin/(m2.min)) at the Clinical Studies Unit at Mayo Clinic Arizona at 7-8 am after an overnight fast. A muscle biopsy will be taken before the insulin infusion, to serve as the resting biopsy (3). Biopsy specimens (150-300 mg) will be frozen immediately in liquid nitrogen and stored in liquid nitrogen until they are processed
VO2max.
VO2max.
Acute exercise bout
The single acute exercise bout will be performed as described (3). It consists of 4 sets of 12 min each (8 min @ 70% VO2max, 2 min @ 90%, 2 min rest, repeat X 4). Biopsies are taken 30 min and 24 hr after end of exercise. Resting biopsies are taken on the glucose clamp day
Percutaneous needle muscle biopsies
Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing. We routinely obtain 150-300 mg muscle (wet weight), which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research. Muscle will be processed either for isolation of mRNA/microRNA or protein, as described (2, 3, 12).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. BMI: Lean, BMI less than or equal to 25; Obese, BMI between 30-40; type 2 diabetic, BMI between 30-40.
3. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
4. Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period.
5. Subjects must range in age as described in each specific protocol.
6. Subjects must have the following laboratory values:
* Hematocrit ≥ 35 vol%
* Serum creatinine ≤ 1.6 mg/dl
* AST (SGOT) \< 2 times upper limit of normal
* ALT (SGPT) \< 2 times upper limit of normal
* Alkaline phosphatase \< 2 times upper limit of normal
* Triglycerides \< 150 mg/dl (except for Aim 4).
Aim 4
1. Age 30-59
2. BMI: Lean, BMI less than or equal to 25; Obese, BMI between 30-40.
3. Patients may have normal or impaired glucose tolerance.
4. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
5. Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period.
6. Subjects must have the following laboratory values:
* Hematocrit ≥ 35 vol%
* Serum creatinine ≤ 1.6 mg/dl
* AST (SGOT) \< 2 times upper limit of normal
* ALT (SGPT) \< 2 times upper limit of normal
* Alkaline phosphatase \< 2 times upper limit of normal
* Triglycerides \> 300 mg/dl for nondiabetics, \> 250 mg/dl for impaired glucose tolerance.
Exclusion Criteria
2. Subjects receiving Gemfibrozil must not also be receiving a statin.
3. Subjects with a history of clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
4. Recent systemic or pulmonary embolus, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, systolic BP\>180, diastolic BP\>105, autonomic neuropathy, resting heart rate \>100, electrolyte abnormalities.
30 Years
59 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arizona State University
OTHER
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lawrence Mandarino
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lawrence J. Mandarino, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Lori Roust, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Scottsdale, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13-006411
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.