Gestational Diabetes
Conditions
Keywords
Diet therapy, Exercise therapy
Brief summary
The aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.
Detailed description
Women who are planning a pregnancy will be recruited into a parallel groups randomised controlled trial where the intervention will consist of high intensity training and time-restricted eating. The intervention will continue throughout pregnancy. The investigators will assess whether this lifestyle intervention can effect maternal and offspring cardiometabolic health.
Interventions
BEHAVIORALtime-restricted eating
Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.
BEHAVIORALhigh intensity exercise
Participants will be encouraged to exercise with high intensity 2-3 times per week
OTHERStandard Care
Standard clinical care
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* contemplating pregnancy within the next six months * At least one of the following criteria: BMI ≥ 25 \< 40 kg/m2, gestational diabetes in a previous pregnancy, previous infant \> 4.5 kg, fasting plasma glucose \> 5.3 mmol/L, or Non-European ethnicity
Exclusion criteria
* On-going pregnancy * Trying to conceive ≥ 6 cycles at study entry * Known diabetes (type 1 or 2) * Shift work that includes night shifts \> 2 days per week * Previous hyperemesis * Known cardiovascular diseases * High intensity exercise ≥ 2 hours/week the last 3 months * Habitual eating window ≤ 12 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose concentration | Gestational week 28 | Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose concentration | Gestational week 12 | Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose) |
| HbA1c | Baseline, intervention week 8, gestational week 12 and 28 | Measured in the maternal blood |
| Total cholesterol | Baseline, intervention week 8, gestational week 12 and 28 | Measured in the maternal blood |
| Triglycerides | Baseline, intervention week 8, gestational week 12 and 28 | Measured in the maternal blood |
| High density lipoprotein cholesterol | Baseline, intervention week 8, gestational week 12 and 28 | Measured in the maternal blood |
| Low density lipoprotein cholesterol | Baseline, intervention week 8, gestational week 12 and 28 | Measured in the maternal blood |
| Low density cholesterol | Baseline, intervention week 8, gestational week 12 and 28 | Measured in the maternal blood |
| Glucose | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | Measured in the blood |
| Insulin | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | Measured in the blood |
| Cytokines | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | Measured in the blood, a panel of 27 cytokines of relevance for inflammatory status (Bio-Plex Pro Human Cytokine 27-plex Assay) |
| Adipokines (Adiponectin, Leptin, Ghrelin) | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | Measured in the maternal blood |
| Homocysteine | Baseline, intervention week 8, gestational week 12 and 28 | Measured in the maternal blood |
| Insulin sensitivity | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5) |
| Total body mass | Baseline, intervention week 8, gestational week 12 and 28 | Estimated using InBody720 bioimpedance scale. |
| Fat mass | Baseline, intervention week 8, gestational week 12 and 28 | Estimated using InBody720 bioimpedance scale. |
| Muscle mass | Baseline, intervention week 8, gestational week 12 and 28 | Estimated using InBody720 bioimpedance scale. |
| Visceral fat area | Baseline, intervention week 8, gestational week 12 and 28 | Estimated using InBody720 bioimpedance scale. |
| Continuous glucose monitoring | Baseline and 8 weeks intervention | Continuous glucose monitoring using Freestyle Libre (Abbott Diabetes Care), worn for 14 days. |
| Cardiorespiratory fitness | Baseline and intervention week 8 | Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer. |
| Blood pressure | Baseline, intervention week 8, gestational week 12 and 28 | Systolic - and diastolic blood pressure (in mmHg) will be measured in the seated position after 15 minutes of rest with an automatic blood pressure device (Welch Allyn, Germany) three times with one minute intervals, in left arm (average of three measurement). |
| Measured physical activity | Baseline | Measured by SenseWear activity monitor, worn for 7 days. |
| Diet intake | Every 8 week throughout the trial. | Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays= |
| Self-reported physical activity | Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline | International Physical Activity Questionnaire |
| Sleep | Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline | Self-reported: Pittsburgh Sleep Quality Index |
| Chronotype | Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline | Self-reported: Hornestberg Morningness Eveningness Questionnaire |
| Psychological general well being | Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline | Psychological general well being index (PGWBI) |
| Time to pregnancy | From baseline to pregnancy (up to 36 weeks from enrollment) | Self-reported |
| Psychological well-being | Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial. | Self-reported: Psychological General Well Being Index |
| Birth weight (infant) | Delivery | From hospital record |
| Birth length (infant) | Delivery | From hospital record |
| Head circumference of infant | Delivery | From hospital record |
| Apgar score | Delivery, after 1, 5 and 10 minutes | From hospital record |
| ICU admission | Delivery | From hospital record |
| Congenital malformation | Delivery | From hospital record |
| Gestational age at birth | Delivery | From hospital record |
| Length of stay at hospital | Delivery | From hospital record |
| Blood pressure (Infant) | Within 72 hours of birth and after 6 weeks post delivery | Blood pressure (systolic - and diastolic) |
| Cardiac function (Infant) | Within 72 hours of birth and after 6 weeks post delivery | Ultrasound echocardiography Blood flow and myocardial function will be measured using mechanical wave imaging (MWI). |
| Infant total body mass | Within 72 hours of birth and after 6 weeks post delivery | Estimated using impedance measurements (BioScan tough i8-nano) |
| Infant muscle mass | Within 72 hours of birth and after 6 weeks post delivery | Estimated using impedance measurements (BioScan tough i8-nano) |
| Infant fat mass | Within 72 hours of birth and after 6 weeks post delivery | Estimated using impedance measurements (BioScan tough i8-nano) |
| Infant hydration status | Within 72 hours of birth and after 6 weeks post delivery | Estimated using impedance measurements (BioScan tough i8-nano) |
| Infant bone mass | Within 72 hours of birth and after 6 weeks post delivery | Estimated using impedance measurements (BioScan tough i8-nano) |
Countries
Norway
Contacts
STUDY_DIRECTORØystein Risa
Norwegian University of Science and Technology, Fac MH ISB
STUDY_DIRECTORKjell Å Salvesen, md prof
St Olavs Hospital, Dept Obstetrics & Gynecology
Outcome results
None listed