NCT00001625

Completed

Methods for Measuring Insulin Sensitivity

National Center for Complementary and Integrative Health (NCCIH)Source

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Other study identifiers

Sponsor study identifier

970105

Secondary identifiers

97-AT-0105

Study Type

observational

Reported enrollment (type unavailable)

480

Locations

1 country

Sites

1

Timeline

Study Start

April 3, 1997

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

April 11, 2007

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 480 participants
Study completion date: April 11, 2007
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 3, 1997
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 3, 1999
Actual (reported)
First Posted
November 4, 1999
Actual (reported)
Study Completion
April 11, 2007
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: July 2, 2017
Status Verified: April 11, 2007
Last Update Submitted: June 30, 2017

Conditions

Diabetes-Mellitus, Non-Insulin Dependent Hypertension Obesity

Keywords

Insulin ResistanceObesityHypertensionDiabetesMathematical ModelingNormal Volunteer

Eligibility Criteria

Age21 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)).

Sponsors & Collaborators

Office of Dietary Supplements (ODS)
NIHcollaborator
National Center for Complementary and Integrative Health (NCCIH)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Related Publications (1)

Quon MJ, Cochran C, Taylor SI, Eastman RC. Non-insulin-mediated glucose disappearance in subjects with IDDM. Discordance between experimental results and minimal model analysis. Diabetes. 1994 Jul;43(7):890-6. doi: 10.2337/diab.43.7.890.
PMID: 8013753BACKGROUND

MeSH Terms

Conditions

ObesityHypertensionDiabetes Mellitus, Type 2Insulin ResistanceDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesGlucose Metabolism Disorders

Study Design

Study Type: observational
Sponsor Type: NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

April 3, 1997

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

April 11, 2007

Date type not reported

This date has not been verified as actual or estimated.

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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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Metabolic Diseases

Endocrine System Diseases

Hyperinsulinism

Last Updated

July 2, 2017

Record last verified: 2007-04-11

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00001625
Data provider: ClinicalTrials.gov
Source updated: 2017-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:02 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations