NCT00928005

Brief Summary

Type 2 diabetes and prediabetes, which are mainly caused by a lack of physical activity and excess weight, put people at an increased risk of cardiovascular disease. This study will compare the effects of a weight loss diet versus a weight loss diet plus an exercise program on body composition and cardiovascular factors that are early predictors of future cardiovascular disease in overweight and obese people with type 2 diabetes and prediabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

2.3 years

First QC Date

June 23, 2009

Last Update Submit

April 1, 2013

Conditions

OverweightObesityType 2 DiabetesPrediabetes

Keywords

Weight loss dietExercise trainingType 2 diabetesPrediabetesCardiovascular health

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular structure and function

    Measured at 6 months

Secondary Outcomes (1)

  • Body composition

    Measured at 6 months

Study Arms (2)

Weight loss diet

ACTIVE COMPARATOR

Participants will follow a low-calorie, low-fat weight loss diet for 6 months.

Behavioral: Weight loss diet

Weight loss diet plus exercise

ACTIVE COMPARATOR

Participants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months.

Behavioral: Weight loss diet plus exercise

Interventions

Weight loss dietBEHAVIORAL

The weight loss diet will follow the American Diabetes Association guidelines and be nutritionally balanced with a reduced saturated fat content.

Weight loss diet
Weight loss diet plus exerciseBEHAVIORAL

The supervised exercise training sessions will take place three times a week for 6 months. Each session will last 1 to 1 ½ hours and will include aerobic exercise and weight training.

Weight loss diet plus exercise

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) 25-42kg/m\^2
  • Type 2 diabetes or prediabetes

You may not qualify if:

  • Currently smokes
  • History or evidence of cardiovascular disease or other major chronic illness
  • Currently exercising regularly or following a weight loss diet
  • Uncontrolled high blood pressure
  • Any illness that would prevent participation in a moderate-intense exercise program
  • Pregnant
  • Substance abuse
  • Use of insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2Prediabetic State

Interventions

Diet, ReducingExercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kerry J Stewart, EDD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)