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

NCT01748305 | Terminated

• 1 other identifier: e8631
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus; Exercise

Keywords

GDM; A1GDM; A2GDM

Outcome Measures

Primary Outcomes (1)

• Need for medication for diabetes

  3 weeks

Secondary Outcomes (3)

• Birth weight

  delivery

• A1c

  delivery

• Mode of delivery

  delivery

Study Arms (1)

Moderate-to-vigorous intensity exercise

EXPERIMENTAL

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

Behavioral: Moderate-to-vigorous intensity exercise

Interventions

Moderate-to-vigorous intensity exercise BEHAVIORAL

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

Moderate-to-vigorous intensity exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• multiple gestation
• non-English speaking
• unable to exercise
• preexisting diabetes

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Antonio Frias, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Jessica Voge, MD

  Oregon Health and Science University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MFM

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

US (1)