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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01748305
Recruitment Status : Terminated (Recruitment issues.)
First Posted : December 12, 2012
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Antonio E. Frias, Oregon Health and Science University

Brief Summary:
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 or disease Intervention/treatment
Gestational Diabetes Mellitus Exercise Behavioral: Moderate-to-vigorous intensity exercise

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study
Study Start Date : December 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Need for medication for diabetes [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Birth weight [ Time Frame: delivery ]
  2. A1c [ Time Frame: delivery ]
  3. Mode of delivery [ Time Frame: delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748305


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
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

Responsible Party: Antonio E. Frias, MD, MFM, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01748305     History of Changes
Other Study ID Numbers: e8631
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015

Keywords provided by Antonio E. Frias, 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