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Completed

NCT Number: NCT01024790

Exercise Study to Help Patients Who Have Type 2 Diabetes and Depression.

The purpose of this study is to test an exercise treatment that includes behavioral strategies to improve blood sugar control in women with type 2 diabetes who are depressed and overweight.This research study may lead to a potentially useful treatment for diabetes management when depression is present.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes, depression, BMI <44,ages between 21-65, female

Exclusion criteria

  • BMI >44, >100 min. of exercise per week, Type 1 diabetes, no diabetes,MI,Stroke, Catheterization, unstable angina in previous 6 months,pregnancy,glucocorticosteroid therapy in last 3 months,bipolar, psychotic disorder or post-traumatic disorder,moving out of area within next 6 weeks

Treatment and study plan

Exercise group

Behavioral

24 week group exercise class supplemented with behavioral activation strategies

Primary outcomes

  1. This research study may lead to a potentially useful treatment for diabetes management when depression is present.

    Time frame: 6 weeks

  2. HbA1c

    Time frame: 3-,6-, and 9-months

  3. Depression

    Time frame: 3-, 6- and 9-months

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2009
Registry last updated
Oct 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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