The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Oral Glucose Tolerance Test
Inactivity
Physical activity
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Prepregnancy BMI > 27
Exclusion Criteria:
- Physical disability that affect movement
Sites / Locations
- Department of Obstetrics and Gynecology, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental intervention
Control intervention
Arm Description
Oral Glucose Tolerance Test and physical activity
Oral Glucose Tolerance Test and inactivity.
Outcomes
Primary Outcome Measures
Blood glucose
Difference in blood glucose between experimental intervention and control intervention.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03644238
Brief Title
The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women
Official Title
The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental intervention
Arm Type
Experimental
Arm Description
Oral Glucose Tolerance Test and physical activity
Arm Title
Control intervention
Arm Type
Other
Arm Description
Oral Glucose Tolerance Test and inactivity.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral Glucose Tolerance Test
Other Intervention Name(s)
OGTT
Intervention Description
75g of glucose is consumed
Intervention Type
Behavioral
Intervention Name(s)
Inactivity
Intervention Description
Lying or sitting down.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
20 minutes of fixed intensity exercise on a bicycle ergometer.
Primary Outcome Measure Information:
Title
Blood glucose
Description
Difference in blood glucose between experimental intervention and control intervention.
Time Frame
Through intervention periods of 2 hours.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Prepregnancy BMI > 27
Exclusion Criteria:
Physical disability that affect movement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Ovesen, MD, Prof.
Organizational Affiliation
Aarhus University Hospital / University of Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32442384
Citation
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.
Results Reference
derived
Learn more about this trial
The Acute Effect of Physical Activity on Blood Glucose in Pregnant Women
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