NCT03641170

Brief Summary

The aim of the project is to investigate the acute effect of exercise on blood glucose after food consumption. Thereby the investigators wish to achieve knowledge that can improve prevention and treatment of gestational overweight and gestational diabetes mellitus (GDM). This will prevent serious complications during pregnancy and birth, but also long term complications like type 2 diabetes mellitus (T2DM) for both the mother and the offspring. Inclusion will be 60 pregnant women divided into three groups - normal weight, overweight and obese and women with gestational diabetes. Participants will receive a fixed diet and go through an intervention period with physical activity immediately after each main meal and a control period with inactivity after the meals. Blood glucose will be the main outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

April 21, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

April 9, 2018

Last Update Submit

April 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Differences in blood glucose between experimental intervention (physical activity) and control intervention (inactivity).

    Through intervention periods of 4 days.

Study Arms (2)

Experimental intervention

EXPERIMENTAL

Fixed diet and physical activity.

Behavioral: Physical activityOther: Fixed diet.

Control intervention

OTHER

Fixed diet and inactivity.

Behavioral: InactivityOther: Fixed diet.

Interventions

Interval walking performed after each main meal.

Experimental intervention
InactivityBEHAVIORAL

Inactivity after each main meal.

Control intervention

Participants will receive a fixed diet through out the intervention period and control period.

Control interventionExperimental intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women over age of 18
  • according to each group: BMI: 18,5-24,9; BMI: \>25; women with GDM.

You may not qualify if:

  • women with a physical disability that affects their movement will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Andersen MB, Fuglsang J, Ostenfeld EB, Poulsen CW, Daugaard M, Ovesen PG. Postprandial interval walking-effect on blood glucose in pregnant women with gestational diabetes. Am J Obstet Gynecol MFM. 2021 Nov;3(6):100440. doi: 10.1016/j.ajogmf.2021.100440. Epub 2021 Jun 30.

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Per Ovesen, MD, Prof.

    Aarhus University Hospital / University of Aarhus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

August 21, 2018

Study Start

April 3, 2018

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

April 21, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations