NCT03644238

Brief Summary

The aim of the project is to investigate the acute effect of exercise on blood glucose after glucose consumption. Thereby we 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. 15 pregnant participants will perform two Oral Glucose Tolerance Tests (OGTT). One is followed by physical activity and the other is followed by inactivity and will serve as control. Blood glucose will be monitored continuously during the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

August 21, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

April 9, 2018

Last Update Submit

May 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Difference in blood glucose between experimental intervention and control intervention.

    Through intervention periods of 2 hours.

Study Arms (2)

Experimental intervention

EXPERIMENTAL

Oral Glucose Tolerance Test and physical activity

Diagnostic Test: Oral Glucose Tolerance TestBehavioral: Physical activity

Control intervention

OTHER

Oral Glucose Tolerance Test and inactivity.

Diagnostic Test: Oral Glucose Tolerance TestBehavioral: Inactivity

Interventions

75g of glucose is consumed

Also known as: OGTT
Control interventionExperimental intervention
InactivityBEHAVIORAL

Lying or sitting down.

Control intervention

20 minutes of fixed intensity exercise on a bicycle ergometer.

Experimental intervention

Eligibility Criteria

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

You may qualify if:

  • Prepregnancy BMI \> 27

You may not qualify if:

  • Physical disability that affect movement

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, Ovesen PG, Daugaard M, Ostenfeld EB, Fuglsang J. Cycling reduces blood glucose excursions after an oral glucose tolerance test in pregnant women: a randomized crossover trial. Appl Physiol Nutr Metab. 2020 Nov;45(11):1247-1252. doi: 10.1139/apnm-2020-0020. Epub 2020 May 22.

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance TestExercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesMotor 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 23, 2018

Study Start

August 21, 2017

Primary Completion

July 27, 2018

Study Completion

August 30, 2018

Last Updated

May 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations