Status:
COMPLETED
Pilot Study of Mitochondrial Biology in Human Platelets
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Insulin Resistance
Diabetes
Eligibility:
All Genders
21-60 years
Brief Summary
Type II diabetes mellitus is rapidly becoming a global pandemic with a deleterious impact on cardiovascular morbidity and mortality. Understanding its pathophysiology is important for the development ...
Detailed Description
Type II diabetes mellitus is rapidly becoming a global pandemic with a deleterious impact on cardiovascular morbidity and mortality. Understanding its pathophysiology is important for the development ...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA:
- Inclusion Criteria (young control group):
- Adults older than 21 years and less than 40 years.
- Insulin sensitivity with a fasting glucose less than 100 mg/dl and a 2-hour post oral glucose tolerance test blood glucose less than 140 mg/dl.
- Subject understands protocol and provides written, informed consent.
- Inclusion Criteria (young insulin-resistant group):
- Adults older than 21 years and less than 40 years.
- Insulin resistance as defined by a fasting blood sugar of greater than or equal to 100mg/dl but less than 125 mg/dl and/or a 2-hour post oral glucose tolerance test blood glucose greater than 140 mg/dl and less than 200 mg/dl.
- Subject understands protocol and provides written, informed consent.
- Inclusion Criteria (middle age control group):
- Adults greater than or equal to 40 years and less than or equal to 60 years.
- Insulin sensitivity with a fasting blood glucose less than 100 mg/dl and a 2-hour post oral glucose tolerance test blood glucose less than 140 mg/dl.
- Subject understands protocol and provides written, informed consent.
- Inclusion Criteria (middle age insulin-resistant group):
- Adults greater than or equal to 40 years and less than or equal to 60 years.
- Insulin resistance as defined by a fasting blood sugar of greater than or equal to 100mg/dl but less than 125 mg/dl and/or a 2-hour post oral glucose tolerance test blood glucose greater than 140 mg/dl and less than 200 mg/dl.
- Subject understands protocol and provides written, informed consent.
- Inclusion Criteria (middle age type II diabetes group):
- Adults greater than or equal to 40 years and less than or equal to 60 years.
- Type II diabetes as defined by a fasting blood sugar of greater than 125 mg/dl and/or a 2-hour post oral glucose tolerance test blood glucose greater than 200 mg/dl if untreated and/or if subjects are on oral hypoglycemic agent therapy where the HbA1c is greater than 6.7 percent.
- Subject understands protocol and provides written, informed consent.
- Exclusion Criteria (all study subjects) :
- Uncontrolled hypertension, heart failure, unstable coronary artery disease or symptomatic peripheral arterial disease requiring changes in medication or medical intervention in the preceding 3 months.
- Insulin-dependant diabetes mellitus or current use of thiazolidinediones.
- Women of childbearing age unless recent pregnancy test is negative and are not breast feeding.
- Serum creatinine greater than 2.5 mg/dl.
- Liver transaminase levels greater than 2.5 times upper limit of normal.
- History of cancer treated with chemotherapy or irradiation in the last 5 years.
- Active inflammatory disease, or infection, or abnormal white blood cell differential.
- Enrollment in any drug studies within the last 30 days.
- BMI greater than 35 for the middle age groups and greater than 30 for the younger subjects.
- Age greater than 60 years.
- Another member of a potential study subject's immediate family has been recruited/participated in this study.
- The use of anticoagulation therapy, thiazide diuretics, corticosteroids, or some psychiatric drugs that cannot be stopped for medical reasons for a few days for study participation.
Exclusion
Key Trial Info
Start Date :
January 27 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 24 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00833846
Start Date
January 27 2009
End Date
October 24 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892