Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03641170 |
| Other study ID # |
Diet study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 3, 2018 |
| Est. completion date |
January 31, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
