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Completed

NCT Number: NCT03644238

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prepregnancy BMI > 27

Exclusion criteria

  • Physical disability that affect movement

Treatment and study plan

Oral glucose tolerance test

Diagnostic Test

75g of glucose is consumed

Other names: OGTT

Inactivity

Behavioral

Lying or sitting down.

Physical activity

Behavioral

20 minutes of fixed intensity exercise on a bicycle ergometer.

Primary outcomes

  1. Blood glucose

    Time frame: Through intervention periods of 2 hours.

    Difference in blood glucose between experimental intervention and control intervention.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2018
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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