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Methods for Measuring Insulin Sensitivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001625
First Posted: November 4, 1999
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

Patients with high blood pressure, diabetes, and who are overweight are known to have defects in the way their body responds to insulin. The purpose of this study is to develop better methods for measuring the way body tissue responds to insulin and sugar (glucose).

Researchers are planning to study four groups of patients.

  1. Normal volunteers
  2. Patients who have mild to moderate high blood pressure
  3. Patients who are overweight
  4. Patients who have mild to moderate diabetes controlled with oral medication

In this study patients and volunteers will undergo two separate tests designed to determine how well insulin is working in the body. The first test is called a glucose clamp test. Patients will have two needles placed in the veins of their arms. One needle will be used to take blood samples, the other needle will be used to inject doses of sugar (glucose) and insulin.

The second test is called the frequently sample intravenous glucose tolerance test. In this test patients will have sugar (glucose) injected into their veins followed by a slow injected dose (infusion) of insulin. Researchers will periodically take blood samples during the test.

Patients participating in the study will not directly benefit from it. However, the information gained from this study may be useful for improving the diagnosis and therapy of diseases such as diabetes, obesity, and high blood pressure (hypertension).


Condition
Obesity Hypertension Diabetes-Mellitus, Non-Insulin Dependent

Study Type: Observational
Official Title: Methods for Assessing Insulin Sensitivity In Vivo

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 480
Study Start Date: April 3, 1997
Estimated Study Completion Date: April 11, 2007
Detailed Description:
We hypothesize that the majority of the information needed to accurately estimate insulin sensitivity is contained in the fasting insulin and glucose levels as well as the insulin and glucose levels obtained shortly after an intravenous glucose load. We propose to test this hypothesis by performing both hyperinsulinemic euglycemic glucose clamps as well as intravenous glucose tolerance tests on normal volunteers and groups of patients with diabetes, hypertension, or obesity (diseases known to be associated with insulin resistance). Data from these studies will be used obtain estimates of insulin sensitivity by the glucose clamp method, minimal model method, and a novel analysis that utilizes only fasting and peak levels of glucose and insulin. We hope to devise a simpler method for determining insulin sensitivity in vivo that is suitable for testing large populations. This method will require only a few blood samples, take less than one hour to perform, and correlate with glucose clamp estimates at least as well as the minimal model method.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Normal Volunteers:

Adults between the ages of 21 and 55 in good general health with no significant underlying illnesses, on no medication, and a normal body mass index (20-26 kg/m(2)).

Obese Subjects:

Adults between the ages of 21 and 55 in good general health with no significant underlying illnesses, on no medication, and a body mass index between 30 and 35 kg/m(2).

Hypertensive Subjects:

Adults between the ages of 21 and 55 in good general health except for mild to moderate hypertension (blood pressure between 140/95 and 170/109 off medication), on no medication except for antihypertensive agents.

Subjects will be taken off all antihypertensive drugs for at least one week prior to study. If a subjects blood pressure exceeds 180/110 on three determinations over a period of at least 15 minutes, the subject will be withdrawn from the study and appropriate antihypertensive therapy resumed.

Diabetic Subjects:

Adults between the ages of 21 and 65 in good general health except for non-insulin dependent diabetes mellitus controlled with oral hypoglycemic agents. Subjects on no other medications. If fasting blood glucose exceeds 300 mg/dl, the subject will be withdrawn from the study and appropriate therapy resumed.

EXCLUSION CRITERIA:

Pregnancy, liver disease, pulmonary disease, end-organ damage such as renal insufficiency, coronary artery disease, heart failure, peripheral vascular disease, proliferative retinopathy, diabetic neuropathy, or HIV infection.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001625


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001625     History of Changes
Other Study ID Numbers: 970105
97-AT-0105
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: July 2, 2017
Last Verified: April 11, 2007

Keywords provided by National Institutes of Health Clinical Center (CC):
Insulin Resistance
Obesity
Hypertension
Diabetes
Mathematical Modeling
Normal Volunteer

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs