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Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus

This study is currently recruiting participants.
Verified December 2012 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Antonio E. Frias, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01748305
First received: December 10, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. All participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. The hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.


Condition Intervention
Gestational Diabetes Mellitus
Exercise
 Behavioral: Moderate-to-vigorous intensity exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Need for medication for diabetes [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Birth weight [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • A1c [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Mode of delivery [ Time Frame: delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate-to-vigorous intensity exercise
Moderate-to-vigorous intensity exercise three times per day for three weeks
 Behavioral: Moderate-to-vigorous intensity exercise
Moderate-to-vigorous intensity exercise three times per day for three weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • gestational diabetes mellitus
  • singelton pregnancy
  • 18 years old or older
  • no medical contraindications to exercise

Exclusion Criteria:

  • multiple gestation
  • non-English speaking
  • unable to exercise
  • preexisting diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748305

Contacts
Contact: Jessica Voge, MD voge@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jessica Voge, MD         voge@ohsu.edu    
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Antonio Frias, MD Oregon Health and Science University
Study Director: Jessica Voge, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Antonio E. Frias, MD, MFM, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01748305     History of Changes
Other Study ID Numbers: e8631
Study First Received: December 10, 2012
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
GDM
A1GDM
A2GDM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 22, 2013