Relation of White Blood Cell Function to Diabetes

NCT00570154 | Completed

• 2 other identifiers: 08002808-H-0028
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Keywords

Mitochondrial Function in Monocytes; Macrophages and Diabetes or Insulin Resistance; Peripheral Blood Mononuclear Cells; Diabetes; Monocyte; Macrophages; Proteome; Type 2 Diabetes; Insulin Resistance; Insulin Sensitivity; Pre-Diabetes; Healthy Volunteer; HV

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.
• 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
• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. 2007 Jul 10;116(2):151-7. doi: 10.1161/CIRCULATIONAHA.106.685628. Epub 2007 Jun 18.

  PMID: 17576864 BACKGROUND

• Morino K, Petersen KF, Shulman GI. Molecular mechanisms of insulin resistance in humans and their potential links with mitochondrial dysfunction. Diabetes. 2006 Dec;55 Suppl 2(Suppl 2):S9-S15. doi: 10.2337/db06-S002.

  PMID: 17130651 BACKGROUND

• Lowell BB, Shulman GI. Mitochondrial dysfunction and type 2 diabetes. Science. 2005 Jan 21;307(5708):384-7. doi: 10.1126/science.1104343.

  PMID: 15662004 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance; Diabetes Mellitus, Type 2; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 10, 2007
• Study Start: November 27, 2007
• Primary Completion: October 19, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-10-19

Locations

US (1)