Status:
UNKNOWN
MOLECULAR REGULATION OF MUSCLE GLUCOSE METABOLISM (AIMS 2A, 2B, 3)
Lead Sponsor:
University of Arizona
Conditions:
Type 2 Diabetes Mellitus
Obesity
Eligibility:
All Genders
21-65 years
Brief Summary
The molecular nature of insulin resistance in human muscle is still incompletely defined. Our data indicate that acetylation of mitochondrial proteins in humans is regulated by muscle contraction and ...
Detailed Description
The purpose of this project has been to define the molecular basis for insulin resistance in human muscle. The preceding two cycles of this project were devoted to using proteomics approaches to map a...
Eligibility Criteria
Inclusion
- Aim 2a. Subjects. Two groups (aged 21-65) will be studied: lean (BMI\<25), healthy insulin sensitive subjects, and obese (BMI\>30) nondiabetics 20 subjects will be enrolled
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- 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.
- Subjects must range in age as described in each specific protocol.
- 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. PT 11.7 -14.3 (During Liposyn/heparin infusion, PT will be determined to insure that it is \< 1.5-2.0 times the normal value.) PTT 23.0-37.0.
- Aim 2b (muscle contraction and acetylation). Subjects. Two groups (aged 21-65) will be studied: lean (BMI\<25), healthy insulin sensitive subjects, and obese (BMI\>30) 32 subjects will be enrolled
- Inclusion Criteria
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- 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.
- Subjects must range in age as described in each specific protocol.
- 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. PT 11.7 -14.3 (During Liposyn/heparin infusion, PT will be determined to insure that it is \< 1.5-2.0 times the normal value.) PTT 23.0-37.0.
- Aim 3 Subjects. Two groups (aged 21-65) will be studied: lean (BMI\<25), healthy insulin sensitive subjects, and obese (BMI\>30) 20 subjects will be enrolled.
- Inclusion Criteria
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- 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.
- Subjects must range in age as described in each specific protocol.
- 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. INR \< 1.3
Exclusion
- Aim 2a
- Subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for the past three months before entry into the study. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. Subjects taking systemic glucocorticoids are excluded.
- 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.
- 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.
- Aim 2b Exclusion Criteria
- Subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for the past three months before entry into the study. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. Subjects taking systemic glucocorticoids are excluded.
- 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.
- 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.
- Aim 3 Exclusion Criteria
- Subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for the past three months before entry into the study. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. Subjects taking systemic glucocorticoids are excluded.
- 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.
- 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.
- Healthy controls with BMI less than 25 who have first degree relatives with Type 2 diabetes are at high risk for insulin resistance, this is an exclusion for this study.
Key Trial Info
Start Date :
November 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2018
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03323827
Start Date
November 1 2016
End Date
August 1 2018
Last Update
October 27 2017
Active Locations (1)
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1
The University of Arizona
Tucson, Arizona, United States, 85724