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

Primary Purpose

Gestational Diabetes Mellitus, Exercise

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Moderate-to-vigorous intensity exercise

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring GDM, A1GDM, A2GDM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Oregon Health & Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Moderate-to-vigorous intensity exercise

Arm Description

Moderate-to-vigorous intensity exercise three times per day for three weeks

Outcomes

Primary Outcome Measures

Need for medication for diabetes

Secondary Outcome Measures

Birth weight

A1c

Mode of delivery

Full Information

NCT ID

NCT01748305

First Posted

December 10, 2012

Last Updated

October 22, 2015

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT01748305

Brief Title

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

Official Title

Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

Recruitment issues.

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes Mellitus, Exercise

Keywords

GDM, A1GDM, A2GDM

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moderate-to-vigorous intensity exercise

Arm Type

Experimental

Arm Description

Moderate-to-vigorous intensity exercise three times per day for three weeks

Intervention Type

Behavioral

Intervention Name(s)

Moderate-to-vigorous intensity exercise

Intervention Description

Moderate-to-vigorous intensity exercise three times per day for three weeks

Primary Outcome Measure Information:

Title

Need for medication for diabetes

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Birth weight

Time Frame

delivery

Title

A1c

Time Frame

delivery

Title

Mode of delivery

Time Frame

delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Frias, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jessica Voge, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Director

Facility Information:

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

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

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