The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women

NCT ID: NCT03644238

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2018-08-30

Brief Summary

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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.

Detailed Description

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Cases: 15 pregnant women recruited at the routine ultrasound scan at gestational week 19 at the Department of Obstetrics and Gynecology, Aarhus University Hospital. Subjects will receive both written and oral information before entering the trial. Subjects with a prepregnancy BMI \> 27 and no other risk factors of diabetes will be included in the study. The women will be examined during gestational week 27-30 where the routine Oral Glucose Tolerance Test (OGTT) will take place. The routine OGTT will serve as control.

Intervention: The subjects will perform two OGTT separated by a minimum of two days. One - the regular OGTT will serve as control and the second OGTT will be the intervention. The two days in between will function as a "wash out period" to avoid potential carry over effect. During the OGTT subjects will consume a liquid containing 75g of glucose. The control OGTT will be followed by inactivity. The intervention OGTT will be immediately followed by 20 minutes of exercise on a bicycle ergometer with a fixed intensity.

Study variables: Blood glucose will be monitored continuously using the IPro2 Continous Glucose Monitor (CGM) from Medtronic. A sensor is inserted into interstitial fluid and continuously generates an electrical current proportional to the glucose concentration. A recorder stores the average sensor current every 5 minutes.

In both control and intervention, blood tests will be taken at time 0, 1 and 2 hours after the OGTT. Blood samples will be analyzed for blood glucose, HbA1c, C-peptide and insulin.

Data on demography, family history of diabetes, prepregnancy BMI, gestational weight gain and complications during pregnancy are collected from medical records of the patients and their offspring.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental intervention

Oral Glucose Tolerance Test and physical activity

Group Type EXPERIMENTAL

Oral Glucose Tolerance Test

Intervention Type DIAGNOSTIC_TEST

75g of glucose is consumed

Physical activity

Intervention Type BEHAVIORAL

20 minutes of fixed intensity exercise on a bicycle ergometer.

Control intervention

Oral Glucose Tolerance Test and inactivity.

Group Type OTHER

Oral Glucose Tolerance Test

Intervention Type DIAGNOSTIC_TEST

75g of glucose is consumed

Inactivity

Intervention Type BEHAVIORAL

Lying or sitting down.

Interventions

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Oral Glucose Tolerance Test

75g of glucose is consumed

Intervention Type DIAGNOSTIC_TEST

Inactivity

Lying or sitting down.

Intervention Type BEHAVIORAL

Physical activity

20 minutes of fixed intensity exercise on a bicycle ergometer.

Intervention Type BEHAVIORAL

Other Intervention Names

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OGTT

Eligibility Criteria

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Inclusion Criteria

* Prepregnancy BMI \> 27

Exclusion Criteria

* Physical disability that affect movement
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Ovesen, MD, Prof.

Role: STUDY_DIRECTOR

Aarhus University Hospital / University of Aarhus

Locations

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Department of Obstetrics and Gynecology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 32442384 (View on PubMed)

Other Identifiers

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OGTT study

Identifier Type: -

Identifier Source: org_study_id

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