Gestational Diabetes Mellitus With Baby DeliveredTRE-HIITmomsNCT07776886
Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes
A study testing Time-restricted eating and exercise in people with Gestational Diabetes Mellitus With Baby Delivered, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This trial will recruit participants who had gestational diabetes in their most previous pregnancy. Participants will be randomly allocated into two groups: one intervention group and one control group 6-12 weeks after giving birth. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus With Baby Delivered
- What is being tested?
- Time-restricted eating and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational diabetes mellitus in most recent pregnancy
- Within 6-12 weeks postpartum
- Understands oral and written Norwegian or English
- Able to walk or run on a treadmill or ride a bike for at least 60 minutes
- Living in the Trondheim area
Who cannot join
- Pregnant or trying to become pregnant
- Diagnosed with type 1 or type 2 diabetes
- Diagnosed with cardiovascular disease
- Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
- Habitual eating window of less than 12 hours/day
- Engaging in regular high-intensity endurance training (once per week or more)
Show all 10Show fewer
- Intention of starting an exercise programme and/or a dietary strategy within the study period
- Shift work that includes night shifts
- Bariatric surgery
- Any other reason which, according to the researchers, makes the potential participant ineligible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Department of Circulation and Medical Imaging
Trondheim, 7491
Trine Moholdt, PhD, +4797098594, trine.moholdt@ntnu.no
Beathe Sitter, PhD, +4799024180, beathe.sitter@ntnu.no
About this study
Official title: Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes (TRE-HIIT Moms)
This trial will recruit participants who had gestational diabetes in their most previous pregnancy. Participants will be randomly allocated into two groups: one intervention group and one control group 6-12 weeks after giving birth. The intervention group will undergo an 8-week supervised intervention consisting of time-restricted eating and endurance exercise training with moderate-to-high intensity. The investigators will assess cardiorespiratory fitness, body composition, and other markers of cardiovascular and metabolic health before and after the 8 weeks. Additionally, the participants in the intervention group will be encouraged to continue exercising and eating time restricted after the supervised period and follow them up by telephone until one year from the baseline visit. The investigators will measure the same outcomes at the follow-up as on the previous two test points.
Read the detailed description
TREHIIT Moms is a randomised, controlled trial with two parallel groups. To be eligible for the trial, the participants need to have had gestational diabetes in their most previous pregnancy and be 6-12 weeks postpartum at inclusion. Participants will be randomly allocated to intervention or control (1:1). The intervention consist of time-restricted eating and endurance exercise. Time-restricted eating implies restricting energy intake to a maximum 10-hour time window daily. The exercise training will be supervised and consist of 2-4 weekly sessions of moderate-to-high intensity exercise. After the supervised period, the participants will continue high-intensity exercise and time-restricted eating at home, with follow-up from the researchers until 1 year from baseline.
The investigators will assess cardiometabolic health outcomes and psychological well-being at baseline, after 8 weeks, and 1 year. Human milk samples will be collected at baseline and 8 weeks and stored for future exploratory analyses of milk composition. The specific analytes and analytical methods will be determined in subsequent exploratory studies and are not prespecified trial outcomes
- Being tested
- Time-restricted eating and exercise
- Keywords
- Exercise, Time-restricted eating, High-intensity interval training
- Medical subject headings
- Motor Activity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eating and exerciseBehavioural
Also called Diet, Exercise
The intervention is a combination of time-restricted eating and endurance exercise training. Time-restricted eating implies that the participants will be asked to limit their energy intake to a maximum 10-hour time window daily. The endurance exercise programme consists of 2-4 weekly supervised exercise sessions for 8 weeks. Thereafter, the participants will continue exercising unsupervised with weekly follow-up from researchers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Time-restricted eating and high-intensity interval training Receives: Behavioral: Time-restricted eating and exercise |
| Control | No intervention | No intervention administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
Measured: From baseline to after 8 weeks
Secondary outcomes (52)
Peak oxygen uptake
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
Measured: From baseline to after 12 months
Body mass
Estimated by bioimpedance scale
Measured: From baseline to after 8 weeks
Body mass
Estimated by bioimpedance scale
Measured: From baseline to after 12 months
Fat mass
Estimated by bioimpedance scale
Measured: From baseline to after 8 weeks
Fat mass
Estimated by bioimpedance scale
Measured: From baseline to after 12 months
Muscle mass
Estimated by bioimpedance scale
Measured: From baseline to after 8 weeks
Muscle mass
Estimated by bioimpedance scale
Measured: From baseline to after 12 months
Visceral fat area
Estimated by bioimpedance scale
Measured: From baseline to after 8 weeks
Visceral fat area
Estimated by bioimpedance scale
Measured: From baseline to after 12 months
Bone mass
Estimated by bioimpedance scale
Measured: From baseline to after 8 weeks
Bone mass
Estimated by bioimpedance scale
Measured: From baseline to after 12 months
Waist circumference
Measured by measuring tape at the level of the umbilicus
Measured: From baseline to after 8 weeks
Waist circumference
Measured by measuring tape at the level of the umbilicus
Measured: From baseline to after 12 months
Systolic blood pressure
Measured by automatic blood pressure cuff
Measured: From baseline to after 8 weeks
Systolic blood pressure
Measured by automatic blood pressure cuff
Measured: From baseline to after 12 months
Diastolic blood pressure
Measured by automatic blood pressure cuff
Measured: From baseline to after 8 weeks
Diastolic blood pressure
Measured by automatic blood pressure cuff
Measured: From baseline to after 12 months
Resting heart rate
Measured by automatic blood pressure cuff
Measured: From baseline to after 8 weeks
Resting heart rate
Measured by automatic blood pressure cuff
Measured: From baseline to after 12 months
Blood cholesterol
Venous blood sampling
Measured: From baseline to after 8 weeks
Blood cholesterol
Venous blood sampling
Measured: From baseline to after 12 months
LDL cholesterol
Venous blood sampling
Measured: From baseline to after 8 weeks
LDL cholesterol
Venous blood sampling
Measured: From baseline to after 12 months
HDL cholesterol
Venous blood sampling
Measured: From baseline to after 8 weeks
HDL cholesterol
Venous blood sampling
Measured: From baseline to after 12 months
Triglycerides
Venous blood sampling
Measured: From baseline to after 8 weeks
Triglycerides
Venous blood sampling
Measured: From baseline to after 12 months
Fasting glucose
Venous blood sampling
Measured: From baseline to after 8 weeks
Fasting glucose
Venous blood sampling
Measured: From baseline to after 12 months
Insulin C-peptide
Venous blood sampling
Measured: From baseline to after 8 weeks
Insulin C-peptide
Venous blood sampling
Measured: From baseline to after 12 months
Plasma glucose after oral glucose tolerance test
Venous blood sampling 120 minutes after ingesting 75 gram glucose
Measured: From baseline to after 8 weeks
Plasma glucose after oral glucose tolerance test
Venous blood sampling 120 minutes after ingesting 75 gram glucose
Measured: From baseline to after 12 months
Dietary intake
Self-reported dietary intake using electronic application
Measured: From baseline to after 8 weeks
Dietary intake
Self-reported dietary intake using electronic application
Measured: From baseline to after 12 months
Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
Participants will wear an ActiGraph accelerometer for 7 consecutive days. Moderate-to-vigorous physical activity will be determined using prespecified accelerometer count thresholds. For each participant, the total number of minutes classified as moderate-to-vigorous physical activity will be calculated for each valid wear day and averaged across all valid wear days. The reported value will be mean minutes of moderate-to-vigorous physical activity per day.
A valid day will be defined as at least 10 hours of accelerometer wear, and participants must have at least 4 valid days to be included in the analysis.
Measured: From baseline to after 8 weeks
Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
Participants will wear an ActiGraph accelerometer for 7 consecutive days. Moderate-to-vigorous physical activity will be determined using prespecified accelerometer count thresholds. For each participant, the total number of minutes classified as moderate-to-vigorous physical activity will be calculated for each valid wear day and averaged across all valid wear days. The reported value will be mean minutes of moderate-to-vigorous physical activity per day.
A valid day will be defined as at least 10 hours of accelerometer wear, and participants must have at least 4 valid days to be included in the analysis.
Measured: From baseline to after 12 months
Self-reported physical activity
International Physical Activity Questionnaire
Measured: From baseline to after 8 weeks
Self-reported physical activity
International Physical Activity Questionnaire
Measured: From baseline to after 12 months
Psychological wellbeing
World Health Organization Five Well-Being Index (WHO-5). The World Health Organization Five Well-Being Index (WHO-5) is a 5-item self-report questionnaire assessing subjective psychological well-being over the previous 2 weeks. Raw scores are transformed to a scale ranging from 0 to 100 by multiplying the total raw score by 4. Higher scores indicate better well-being.
Measured: From baseline to after 8 weeks
Psychological wellbeing
World Health Organization Five Well-Being Index (WHO-5). The World Health Organization Five Well-Being Index (WHO-5) is a 5-item self-report questionnaire assessing subjective psychological well-being over the previous 2 weeks. Raw scores are transformed to a scale ranging from 0 to 100 by multiplying the total raw score by 4. Higher scores indicate better well-being.
Measured: From baseline to after 12 months
Sleep quality
Pittsburgh Sleep Quality Index questionnaire global score. The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the previous month. The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: From baseline to after 8 weeks
Sleep quality
Pittsburgh Sleep Quality Index questionnaire global score. The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses sleep quality over the previous month. The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: From baseline to after 12 months
Depression
The Edinburgh Postnatal Depression Scale (EPDS) global score. The Edinburgh Postnatal Depression Scale is a 10-item self-report questionnaire that assesses symptoms of depression over the previous 7 days. The total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.
Measured: From baseline to 8 weeks
Depression
The Edinburgh Postnatal Depression Scale (EPDS) global score. The Edinburgh Postnatal Depression Scale is a 10-item self-report questionnaire that assesses symptoms of depression over the previous 7 days. The total score ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.
Measured: From baseline to after 12 months
Anxiety
Generalised anxiety disorder questionnaire (GAD-7) total score. The Generalized Anxiety Disorder 7-Item (GAD-7) is a 7-item self-report questionnaire that assesses symptoms of generalized anxiety over the previous 2 weeks. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: From baseline to after 8 weeks
Anxiety
Generalised anxiety disorder questionnaire (GAD-7) total score. The Generalized Anxiety Disorder 7-Item (GAD-7) is a 7-item self-report questionnaire that assesses symptoms of generalized anxiety over the previous 2 weeks. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: From baseline to after 12 months
Type 2 diabetes mellitus diagnosis
Participant-reported or measurement of HbA1c of 48 mmol/mol or above
Measured: During the 12-month follow-up
Mean Daily Step Count Measured by ActiGraph Accelerometer
Participants will wear an ActiGraph accelerometer for 7 consecutive days. The number of steps recorded on each valid wear day will be averaged across all valid wear days for each participant. A valid day will be defined as at least 10 hours of accelerometer wear, and at least 4 valid days will be required.
Measured: From baseline to after 8 weeks
Mean Daily Sedentary Time Measured by ActiGraph Accelerometer
Participants will wear an ActiGraph accelerometer for 7 consecutive days. Sedentary time will be identified using a prespecified accelerometer count threshold. Minutes classified as sedentary will be calculated for each valid wear day and averaged across all valid wear days for each participant. A valid day will be defined as at least 10 hours of accelerometer wear, and at least 4 valid days will be required.
Measured: At baseline and after 8 weeks
Mean Daily Step Count Measured by ActiGraph Accelerometer
Participants will wear an ActiGraph accelerometer for 7 consecutive days. The number of steps recorded on each valid wear day will be averaged across all valid wear days for each participant. A valid day will be defined as at least 10 hours of accelerometer wear, and at least 4 valid days will be required.
Measured: From baseline to after 12 months
Mean Daily Sedentary Time Measured by ActiGraph Accelerometer
Participants will wear an ActiGraph accelerometer for 7 consecutive days. Sedentary time will be identified using a prespecified accelerometer count threshold. Minutes classified as sedentary will be calculated for each valid wear day and averaged across all valid wear days for each participant. A valid day will be defined as at least 10 hours of accelerometer wear, and at least 4 valid days will be required.
Measured: From baseline to after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus With Baby DeliveredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Trine Moholdt, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776886
- Sponsor's protocol ID
- 987380
- Acronym
- TRE-HIITmoms
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make de-identified individual participant data (IPD) collected in the study available to other researchers. We will upload a data set in an open access repository. We will only share IPD that cannot be used to identify individuals.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes (TRE-HIIT Moms)
- ClinicalTrials.gov ID
- NCT07776886
- Acronym / sponsor ID
- TRE-HIITmoms / 987380
- Keywords
- Exercise, Time-restricted eating, High-intensity interval training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will recruit participants who had gestational diabetes in their most previous pregnancy. Participants will be randomly allocated into two groups: one intervention group and one control group 6-12 weeks after giving birth. The intervention group will undergo an 8-week supervised intervention consisting of time-restricted eating and endurance exercise training with moderate-to-high intensity. The investigators will assess cardiorespiratory fitness, body composition, and other markers of cardiovascular and metabolic health before and after the 8 weeks. Additionally, the participants in the intervention group will be encouraged to continue exercising and eating time restricted after the supervised period and follow them up by telephone until one year from the baseline visit. The investigators will measure the same outcomes at the follow-up as on the previous two test points.
Detailed description
TREHIIT Moms is a randomised, controlled trial with two parallel groups. To be eligible for the trial, the participants need to have had gestational diabetes in their most previous pregnancy and be 6-12 weeks postpartum at inclusion. Participants will be randomly allocated to intervention or control (1:1). The intervention consist of time-restricted eating and endurance exercise. Time-restricted eating implies restricting energy intake to a maximum 10-hour time window daily. The exercise training will be supervised and consist of 2-4 weekly sessions of moderate-to-high intensity exercise. After the supervised period, the participants will continue high-intensity exercise and time-restricted eating at home, with follow-up from the researchers until 1 year from baseline.
The investigators will assess cardiometabolic health outcomes and psychological well-being at baseline, after 8 weeks, and 1 year. Human milk samples will be collected at baseline and 8 weeks and stored for future exploratory analyses of milk composition. The specific analytes and analytical methods will be determined in subsequent exploratory studies and are not prespecified trial outcomes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Time-restricted eating and exerciseTime-restricted eating and high-intensity interval training |
| Control | No intervention | –No intervention administered |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gestational diabetes mellitus in most recent pregnancy
- Within 6-12 weeks postpartum
- Understands oral and written Norwegian or English
- Able to walk or run on a treadmill or ride a bike for at least 60 minutes
- Living in the Trondheim area
Key exclusion criteria (10 listed)
- Pregnant or trying to become pregnant
- Diagnosed with type 1 or type 2 diabetes
- Diagnosed with cardiovascular disease
- Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
- Habitual eating window of less than 12 hours/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eating and exerciseAlso: Diet, ExerciseThe intervention is a combination of time-restricted eating and endurance exercise training. Time-restricted eating implies that the participants will be asked to limit their energy intake to a maximum 10-hour time window daily. The endurance exercise programme consists of 2-4 weekly supervised exercise sessions for 8 weeks. Thereafter, the participants will continue exercising unsupervised with weekly follow-up from researchers. | Behavioural | Intervention |
Primary outcome
Peak oxygen uptake
Time frame: From baseline to after 8 weeks
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
52 secondary outcomes
Peak oxygen uptake
Time frame: From baseline to after 12 months
Body mass
Time frame: From baseline to after 8 weeks
Body mass
Time frame: From baseline to after 12 months
Fat mass
Time frame: From baseline to after 8 weeks
Fat mass
Time frame: From baseline to after 12 months
Muscle mass
Time frame: From baseline to after 8 weeks
Muscle mass
Time frame: From baseline to after 12 months
Visceral fat area
Time frame: From baseline to after 8 weeks
Visceral fat area
Time frame: From baseline to after 12 months
Bone mass
Time frame: From baseline to after 8 weeks
Bone mass
Time frame: From baseline to after 12 months
Waist circumference
Time frame: From baseline to after 8 weeks
Waist circumference
Time frame: From baseline to after 12 months
Systolic blood pressure
Time frame: From baseline to after 8 weeks
Systolic blood pressure
Time frame: From baseline to after 12 months
Diastolic blood pressure
Time frame: From baseline to after 8 weeks
Diastolic blood pressure
Time frame: From baseline to after 12 months
Resting heart rate
Time frame: From baseline to after 8 weeks
Resting heart rate
Time frame: From baseline to after 12 months
Blood cholesterol
Time frame: From baseline to after 8 weeks
Blood cholesterol
Time frame: From baseline to after 12 months
LDL cholesterol
Time frame: From baseline to after 8 weeks
LDL cholesterol
Time frame: From baseline to after 12 months
HDL cholesterol
Time frame: From baseline to after 8 weeks
HDL cholesterol
Time frame: From baseline to after 12 months
Triglycerides
Time frame: From baseline to after 8 weeks
Triglycerides
Time frame: From baseline to after 12 months
Fasting glucose
Time frame: From baseline to after 8 weeks
Fasting glucose
Time frame: From baseline to after 12 months
Insulin C-peptide
Time frame: From baseline to after 8 weeks
Insulin C-peptide
Time frame: From baseline to after 12 months
Plasma glucose after oral glucose tolerance test
Time frame: From baseline to after 8 weeks
Plasma glucose after oral glucose tolerance test
Time frame: From baseline to after 12 months
Dietary intake
Time frame: From baseline to after 8 weeks
Dietary intake
Time frame: From baseline to after 12 months
Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
Time frame: From baseline to after 8 weeks
Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer
Time frame: From baseline to after 12 months
Self-reported physical activity
Time frame: From baseline to after 8 weeks
Self-reported physical activity
Time frame: From baseline to after 12 months
Psychological wellbeing
Time frame: From baseline to after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. We will make de-identified individual participant data (IPD) collected in the study available to other researchers. We will upload a data set in an open access repository. We will only share IPD that cannot be used to identify individuals.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trine Moholdt, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating and exercise in people with Gestational Diabetes Mellitus With Baby Delivered, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trine Moholdt, PhD (+4797098594, trine.moholdt@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: From baseline to after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.