Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone

NCT ID: NCT00737347

Last Updated: 2008-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-04-30

Brief Summary

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The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.

Detailed Description

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The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)

Conditions

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Type 2 Diabetes Obesity

Keywords

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type 2 diabetes obesity weight gain thiazolidinediones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

usual care. Subjects had one 90 minute visit with registered dietitian

Group Type NO_INTERVENTION

No interventions assigned to this group

2.

Standard care. Subjects had 4 sessions with registered dietitian

Group Type ACTIVE_COMPARATOR

Lifestyle modification

Intervention Type BEHAVIORAL

lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling

3

Intensive care. subjects had 10 visits with registered dietitian

Group Type ACTIVE_COMPARATOR

Lifestyle modification

Intervention Type BEHAVIORAL

lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling

Interventions

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Lifestyle modification

lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling

Intervention Type BEHAVIORAL

Other Intervention Names

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lifestyle behavioral counseling

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater

Exclusion Criteria

* insulin treated
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Northwestern University

Principal Investigators

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Robert F Kushner, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Memorial Hospital Wellness Institute

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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0309-015

Identifier Type: -

Identifier Source: org_study_id