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

Northwestern University

Status and phase: Completed; Phase 3

Conditions: Obesity; Type 2 Diabetes

Treatments: Behavioral: Lifestyle modification

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00737347

0309-015

Details and patient eligibility

About

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.

Full description

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

Enrollment: 39 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• insulin treated

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

1

No Intervention group

Description:

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

2.

Active Comparator group

Description:

Standard care. Subjects had 4 sessions with registered dietitian

Treatment:

Behavioral: Lifestyle modification

3

Active Comparator group

Description:

Intensive care. subjects had 10 visits with registered dietitian

Treatment:

Behavioral: Lifestyle modification