NCT00001625

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2007

Completed
Last Updated

July 2, 2017

Status Verified

April 11, 2007

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

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)).
  • 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.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

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 DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinism

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

Study Completion

April 11, 2007

Last Updated

July 2, 2017

Record last verified: 2007-04-11

Locations