Protocol Number: 08-H-0028

Title:

Pilot Study of Monocyte Biology in Insulin Sensitive, Resistant and Diabetic Subjects

Number:

08-H-0028

Summary:

Background:

Patients who are pre-diabetic or have adult onset (type 2) diabetes have a significantly greater risk of developing heart, blood vessel, or kidney diseases.

Recent studies have shown that abnormalities in white blood cell function may increase the chances of developing insulin resistance, the underlying problem in diabetic or pre-diabetic patients.

Objectives:

To determine levels of insulin sensitivity in selected volunteers.

To compare the white blood cells of non-diabetic, pre-diabetic, and type 2 (adult onset) diabetic volunteers to evaluate possible differences in white blood cell function.

Eligibility:

Individuals between 21 and 60 years of age who (1) are non-diabetic, (2) are pre-diabetic (glucose intolerant or insulin resistant), or (3) have type 2 diabetes that is controlled by diet and/or medications other than insulin.

Design:

Evaluations before treatment:

-Blood tests, including screening procedures for blood-transmitted diseases such as hepatitis B and C, insulin sensitivity and glucose tolerance tests, and liver and kidney function tests.

-Pregnancy tests for women of childbearing age.

Two tests will be performed during the study period:

-Glucose tolerance test to determine how well the body uses glucose.

-Blood drawn to study white blood cells.

Participants will be financially compensated for the time spent during the study.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA (young groups)

Adults older than 21 years and less than 40 years

Subjects must either have:

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

or

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 groups)

Adults greater than or equal to 40 years and less than or equal to 60 years

Subjects must either have:

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

or

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.

or

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 volunteers and subjects)

Uncontrolled hypertension or therapy with a Beta-blocker

History of heart failure (or ejection fraction less than 55 percent by echocardiogram), 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 you 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 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 group and greater than 30 for the younger subjects

Special Instructions:

Currently Not Provided

Keywords:

Mitochondrial Function in Monocytes

Macrophages and Diabetes or Insulin Resistance

Peripheral Blood Mononuclear Cells

Diabetes

Monocyte

Macrophages

Proteome

Recruitment Keyword(s):

Type 2 Diabetes

Insulin Resistance

Insulin Sensitivity

Pre-Diabetes

Healthy Volunteer

HV

Condition(s):

Diabetes

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Heart, Lung, and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Barr EL, Zimmet PZ, Welborn TA, Jolley D, Magliano DJ, Dunstan DW, Cameron AJ, Dwyer T, Taylor HR, Tonkin AM, Wong TY, McNeil J, Shaw JE. Risk of cardiovascular and all-cause mortality in individuals with diabetes mellitus, impaired fasting glucose, and impaired glucose tolerance: the Australian Diabetes, Obesity and Lifestyle Study (AusDiab). Circulation. Jul 10 2007; 116(2): 151-157.

Morino K, Peterson KF, Shulman GI. Molecular mechanisms of insulin resistance in humans and their potential links with mitochondrial dysfunction. Diabetes. Dec 2006; 55 Suppl 2: S9-S15.

Lowell BB, Shulman GI. Mitochondrial dysfunction and type 2 diabetes. Science. Jan 21 2005; 307(5708):384-387.

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