Status:

COMPLETED

Feasibility of a Partnered Approach to Prevent Diabetes

Lead Sponsor:

Northwestern University

Conditions:

Pre-diabetic State

Overweight

Eligibility:

All Genders

25+ years

Phase:

NA

Brief Summary

The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can delay or prevent the development of type...

Eligibility Criteria

Inclusion

  • 25 years of age or older Body-mass index of \>= 24 kg/m2
  • or more additional risk factors if age is \<45
  • \- Parent or sibling with diabetes
  • Minority race or ethnicity
  • History of gestational diabetes
  • Delivery of infant \>= 9 lbs.
  • History of high blood pressure
  • History of dyslipidemia
  • Polycystic Ovarian Syndrome
  • History of vascular disease Fasting Capillary Glucose 95 - 125 mg/dl 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl

Exclusion

  • Diseases that could limit lifespan or increase risk with a lifestyle intervention - Cancer diagnosed in the past 5 years
  • \- Significant Cardiovascular Disease
  • \- A "Yes" response to any item on the modified Physical Activity Readiness Questionnaire
  • \- Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg
  • Heart attack, stroke, or transient ischemic attack within 6 months
  • Chest pain or unexplained dizziness or fainting with physical exertion
  • Chronic obstructive pulmonary disease or asthma needing home oxygen
  • Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to \<5 years
  • Any other known reason for not participating in regular physical activity
  • Exclusions related to metabolism - Past anti-diabetes medication use, except during gestational diabetes
  • \- Use of a medications known to produce hyperglycemia
  • \- Known disease leading to abnormal glucose metabolism
  • Exclusions for conditions / behaviors likely to affect study conduct
  • \- Unable or unwilling to provide informed consent
  • Unable to communicate with the pertinent clinic staff
  • Unable to read written English or Spanish

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT00302055

Start Date

March 1 2006

End Date

July 1 2007

Last Update

December 1 2016

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

IU Medical Group Westside Clinic

Indianapolis, Indiana, United States, 46222

2

IU Medical Group Banta Road Clinic

Indianapolis, Indiana, United States, 46227