Moderate-to-vigorous Physical Activity for Glycemic Contr... | NCT01748305

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

NCT01748305

Sponsor

Oregon Health and Science University

Status

Terminated

Last Update Posted

Oct 23, 2015Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Gestational Diabetes Mellitus
Exercise

Interventions

Moderate-to-vigorous intensity exercise

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment issues.

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 10, 2012

First Submission Date that Met QC Criteria

Dec 11, 2012

First Posted Date

Dec 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2015

Last Update Posted Date

Oct 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antonio E. Frias, MD, MFM, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Moderate-to-vigorous intensity exercise	Behavioral	Moderate-to-vigorous intensity exercise three times per day for three weeks	Moderate-to-vigorous intensity exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Need for medication for diabetes		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Birth weight		delivery
A1c		delivery
Mode of delivery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antonio Frias, MD	Oregon Health and Science University	Principal Investigator
Jessica Voge, MD	Oregon Health and Science University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational
D009043	Motor Activity

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided