The Acute Effect of Physical Activity on Postprandial Blood Glucose in Pregnant Women
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical activity
Inactivity
Fixed diet.
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Pregnant women over age of 18
- according to each group: BMI: 18,5-24,9; BMI: >25; women with GDM.
Exclusion Criteria:
- women with a physical disability that affects their movement will be excluded from the study
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
Fixed diet and physical activity.
Fixed diet and inactivity.
Outcomes
Primary Outcome Measures
Blood glucose
Differences in blood glucose between experimental intervention (physical activity) and control intervention (inactivity).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03641170
Brief Title
The Acute Effect of Physical Activity on Postprandial Blood Glucose in Pregnant Women
Official Title
The Acute Effect of Physical Activity on Postprandial Blood Glucose in Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (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 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.
Detailed Description
Design: Crossover controlled study. Cases: 60 pregnant women recruited at the Department of Obstetrics and Gynecology, Aarhus University Hospital (AUH). Subjects will receive both written and oral information before entering the trial. According to their prepregnancy BMI, subjects will be recruited for three different groups: i) normal weight (BMI 18,5-24,9), ii) overweight and obese (BMI ≥ 25) and iii) GDM. 20 women in each group. Group i and ii will be recruited at the routine ultrasound scan at gestational week 19. Group iii will be recruited after the Oral Glucose Tolerance Test (OGTT) that diagnoses gestational diabetes mellitus. The routine OGTT is done at gestational week 28. When diagnosed with GDM the women are referred to Department of Obstetrics and Gynecology, AUH, and the investigators will recruit participants from here. Participants will be examined during gestational week 30-34 where insulin resistance peaks during pregnancy.
Intervention: Participants will receive a fixed diet for a total of 8 days. The 8 days of fixed diet are split into a 4 days intervention period and a 4 days control period separated by two days of regular food intake. The two days of regular food intake will function as a "wash out period" to avoid carry over effect. During the 4 days intervention period the participants will perform 30 minutes of interval walking immediately after each main meal. The interval walking consists of alternating fast and slow intervals (3 minutes each) aiming at > 70% and < 40% of peak energy expenditure measured by the Sensewear Armband. During the 4 days control period the participants will be normally active, not performing any set physical activity. Participants will be randomized to the order of the two periods.
Study variables: Fasting blood samples will be taken on the first day of both the intervention and control period and on the morning after the last day of each period. Blood samples will be analyzed for blood glucose, HbA1c, C-peptide and lipid profile (triglycerides, HDL and LDL).
During the entire experimental period, movement data will be collected using the Sensewear Armband. Blood glucose will be monitored continuously using the IPro2 Continuous Glucose Monitor (CGM) from Medtronic.
The diet will consist of three main meals and three snacks and will be calculated to match their metabolic need. The calculations will be done by a nutrition specialist and will include weight, height, BMI and energy need during 3rd trimester pregnancy.
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
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental intervention
Arm Type
Experimental
Arm Description
Fixed diet and physical activity.
Arm Title
Control intervention
Arm Type
Other
Arm Description
Fixed diet and inactivity.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
Interval walking performed after each main meal.
Intervention Type
Behavioral
Intervention Name(s)
Inactivity
Intervention Description
Inactivity after each main meal.
Intervention Type
Other
Intervention Name(s)
Fixed diet.
Intervention Description
Participants will receive a fixed diet through out the intervention period and control period.
Primary Outcome Measure Information:
Title
Blood glucose
Description
Differences in blood glucose between experimental intervention (physical activity) and control intervention (inactivity).
Time Frame
Through intervention periods of 4 days.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women over age of 18
according to each group: BMI: 18,5-24,9; BMI: >25; women with GDM.
Exclusion Criteria:
women with a physical disability that affects their movement will be excluded from the study
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
34216833
Citation
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.
Results Reference
derived
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The Acute Effect of Physical Activity on Postprandial Blood Glucose in Pregnant Women
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