Type 2 Diabetes MellitusNCT02982408
Impact of Overfeeding and Following Exercise Training in Individuals With and Without Increased Risk of Type 2 Diabetes
A study testing High carbohydrate overfeeding, Exercise and Normal physical activity in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Low birth weight (LBW), a marker of impaired fetal growth is an independent and strong risk factor for type 2 diabetes (T2D). A western lifestyle characterized by a surplus of calories, and/or a low physical activity level, associated with increased fat storage and altered lipid metabolism plays a central role in the… Read more about this study
- Who is it for?
- Ages 35 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Insulin Resistance, Dyslipidemia
- What is being tested?
- High carbohydrate overfeeding, Exercise and Normal physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- without known disease (approved health examination)
- caucasian
- born at term (weeks 39-41) in Denmark
- recruited from the national Danish Birth Registry
- born with either low or normal birthweight (see previous)
Who cannot join
- family history of diabetes in two generations (1st and 2nd degree relatives)
- self-reported high physical activity level (>10hrs /week).
- weight loss/gain >3 kg within the past 6 months
- alcohol intake of more than general recommendations
- substance abuser
- intake of medication know to affect outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Exercise Training Revert and/or Minimize the Deleterious Cardiometabolic Effects of Carbohydrate Overfeeding in Individuals With and Without Increased Risk of Type 2 Diabetes?
Low birth weight (LBW), a marker of impaired fetal growth is an independent and strong risk factor for type 2 diabetes (T2D). A western lifestyle characterized by a surplus of calories, and/or a low physical activity level, associated with increased fat storage and altered lipid metabolism plays a central role in the pathogenesis of insulin resistance and T2D. Using state-of-the-art large-scale integrative physiology studies combined with basic studies of adipose and muscle tissue stem cell functions, the investigators aim to determine if LBW individuals exhibit decreased subcutaneous adipose tissue expandability, postprandial hyperlipidaemia and ectopic fat accumulation when exposed to 4 weeks of carbohydrate overfeeding. The investigators will subsequently examine if exercise training can revert and/or minimize the deleterious effects of carbohydrate overfeeding in a possibly birth weight differential manner.
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance, Dyslipidemia
- Being tested
- High carbohydrate overfeeding, Exercise, Normal physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High carbohydrate overfeedingDietary supplement
All participant's individual energy requirement will be determined in mega joules (MJ) per day. The energy requirement will be multiplied by a factor 1.5 for a low physical activity level (PAL). The MJ will be rounded up or down to the nearest whole number.
The participant will receive food corresponding to ~25% additional energy above their calculated energy requirement. The 25% extra energy will be supplied to the participants for 4 weeks in the form of food containing simple carbohydrates. The subjects will be given a daily snack package containing processed foods or refined foods such as sweets, cookies, soft drinks, juice etc. To ensure an adequate energy surplus (i.e. weight gain), physical activity has to be decreased to a low level during the 4 weeks overfeeding period.
ExerciseBehavioural
Half of the participants will be randomized to a 3-month exercise-training program.
The training program consists of combined aerobic training and strength training. The training program is performed unsupervised 3 times per week 45 minutes per session for 3 months in the local fitness center. Before engaging in the training program a maximal oxygen consumption test (VO2 max) are conducted and the maximal heartrate (HR) are determined.Participants are wearing the Polar V800 HR monitor and are asked to note their HR in a training log at the end of the last interval at each training session. The strength training program consist of 6 exercises (2 exercises paired together) involving the large muscle groups. The first training session is completed supervised at Rigshospitalet . After 6 weeks the training program is adjusted. Compliance will be ensured by phone calls, text messages and e-mails from study personnel.
Normal physical activityBehavioural
The other half of the participants will be randomized to a 3-month with normal physical activity level (control).
The participants will have to return to the physical activity level they had before entering the study (baseline level). Compliance will be ensured by phone calls and text messages from study personnel. The subjects will wear a simple pedometer on the hip showing the number of steps. Once a week a text message (SMS-track) is automatically sent asking the participants to enter the weekly number of steps. The test personnel receive the reply and contact the participant if the number of steps does not match the baseline level. During the first and the last 7 days of the exercise intervention participants are wearing 2 accelerometers measuring their physical activity behavior.
| Study group | Role | What they receive |
|---|---|---|
| Low birth weight (LBW) | Experimental | 25 males born at term (weeks 39-41) in 1979-1981 with LBW (BW<10th percentile) Receives: Dietary Supplement: High carbohydrate overfeeding; Behavioral: Exercise; Behavioral: Normal physical activity |
| Normal birth weight (NBW) | Experimental | 25 BMI- and age-matched males born at term (weeks 39-41) with normal birth weight (NBW) control individuals (BW: 50-90th percentile) Receives: Dietary Supplement: High carbohydrate overfeeding; Behavioral: Exercise; Behavioral: Normal physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue expandability
Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups
Measured: baseline
Adipose tissue expandability
Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups
Measured: Difference between the two groups at baseline, after 4 weeks overfeeding and after 12 weeks exercise training.
Secondary outcomes (3)
Glucose turnover rate
Turnover rates will be measured after a 5 hr mealtest by use isotopic tracers in the two groups
Measured: Baseline, 4 weeks overfeeding, 12 weeks training
Lipid turnover rate
Turnover rates will be measured after a 5 hr mealtest by use isotopic tracers in the two groups
Measured: Baseline, 4 weeks overfeeding, 12 weeks training
Epigenetics
Marks of adipose tissue, skeletal muscle stem cell and differentiated cell type genomes.
Measured: Baseline, 4 weeks overfeeding, 12 weeks training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Augustinus Fonden
- Responsible party
- Principal investigator, Charlotte Brøns, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Charlotte Brøns, PhD, Principal investigator, Copenhagen University Hospital, RigshospitaletAllan Vaag, PhD, DMsc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982408
- Sponsor's protocol ID
- H-4-2014-128
- Status last verified
- Sep 2019
- First submitted
- 23 Aug 2016
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Exercise Training Revert and/or Minimize the Deleterious Cardiometabolic Effects of Carbohydrate Overfeeding in Individuals With and Without Increased Risk of Type 2 Diabetes?
- ClinicalTrials.gov ID
- NCT02982408
- Acronym / sponsor ID
- H-4-2014-128
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Augustinus Fonden
- Study start
- Aug 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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.
Low birth weight (LBW), a marker of impaired fetal growth is an independent and strong risk factor for type 2 diabetes (T2D). A western lifestyle characterized by a surplus of calories, and/or a low physical activity level, associated with increased fat storage and altered lipid metabolism plays a central role in the pathogenesis of insulin resistance and T2D. Using state-of-the-art large-scale integrative physiology studies combined with basic studies of adipose and muscle tissue stem cell functions, the investigators aim to determine if LBW individuals exhibit decreased subcutaneous adipose tissue expandability, postprandial hyperlipidaemia and ectopic fat accumulation when exposed to 4 weeks of carbohydrate overfeeding. The investigators will subsequently examine if exercise training can revert and/or minimize the deleterious effects of carbohydrate overfeeding in a possibly birth weight differential manner.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low birth weight (LBW) | Experimental | Dietary Supplement: High carbohydrate overfeeding, Behavioral: Exercise, Behavioral: Normal physical activity25 males born at term (weeks 39-41) in 1979-1981 with LBW (BW<10th percentile) |
| Normal birth weight (NBW) | Experimental | Dietary Supplement: High carbohydrate overfeeding, Behavioral: Exercise, Behavioral: Normal physical activity25 BMI- and age-matched males born at term (weeks 39-41) with normal birth weight (NBW) control individuals (BW: 50-90th percentile) |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- without known disease (approved health examination)
- caucasian
- born at term (weeks 39-41) in Denmark
- recruited from the national Danish Birth Registry
- born with either low or normal birthweight (see previous)
Key exclusion criteria (6 listed)
- family history of diabetes in two generations (1st and 2nd degree relatives)
- self-reported high physical activity level (>10hrs /week).
- weight loss/gain >3 kg within the past 6 months
- alcohol intake of more than general recommendations
- substance abuser
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 |
|---|---|---|
| High carbohydrate overfeedingAll participant's individual energy requirement will be determined in mega joules (MJ) per day. The energy requirement will be multiplied by a factor 1.5 for a low physical activity level (PAL). The MJ will be rounded up or down to the nearest whole number. The participant will receive food corresponding to ~25% additional energy above their calculated energy requirement. The 25% extra energy will be supplied to the participants for 4 weeks in the form of food containing simple carbohydrates. The subjects will be given a daily snack package containing processed foods or refined foods such as sweets, cookies, soft drinks, juice etc. To ensure an adequate energy surplus (i.e. weight gain), physical activity has to be decreased to a low level during the 4 weeks overfeeding period. | Dietary supplement | Low birth weight (LBW), Normal birth weight (NBW) |
| ExerciseHalf of the participants will be randomized to a 3-month exercise-training program. The training program consists of combined aerobic training and strength training. The training program is performed unsupervised 3 times per week 45 minutes per session for 3 months in the local fitness center. Before engaging in the training program a maximal oxygen consumption test (VO2 max) are conducted and the maximal heartrate (HR) are determined.Participants are wearing the Polar V800 HR monitor and are asked to note their HR in a training log at the end of the last interval at each training session. The strength training program consist of 6 exercises (2 exercises paired together) involving the large muscle groups. The first training session is completed supervised at Rigshospitalet . After 6 weeks the training program is adjusted. Compliance will be ensured by phone calls, text messages and e-mails from study personnel. | Behavioural | Low birth weight (LBW), Normal birth weight (NBW) |
| Normal physical activityThe other half of the participants will be randomized to a 3-month with normal physical activity level (control). The participants will have to return to the physical activity level they had before entering the study (baseline level). Compliance will be ensured by phone calls and text messages from study personnel. The subjects will wear a simple pedometer on the hip showing the number of steps. Once a week a text message (SMS-track) is automatically sent asking the participants to enter the weekly number of steps. The test personnel receive the reply and contact the participant if the number of steps does not match the baseline level. During the first and the last 7 days of the exercise intervention participants are wearing 2 accelerometers measuring their physical activity behavior. | Behavioural | Low birth weight (LBW), Normal birth weight (NBW) |
Primary outcome
Adipose tissue expandability
Time frame: baseline
Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups
Adipose tissue expandability
Time frame: Difference between the two groups at baseline, after 4 weeks overfeeding and after 12 weeks exercise training.
Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups
3 secondary outcomes
Glucose turnover rate
Time frame: Baseline, 4 weeks overfeeding, 12 weeks training
Lipid turnover rate
Time frame: Baseline, 4 weeks overfeeding, 12 weeks training
Epigenetics
Time frame: Baseline, 4 weeks overfeeding, 12 weeks training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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. This study is not recruiting at the moment.
Charlotte Brøns, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
Allan Vaag, PhD, DMsc study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High carbohydrate overfeeding, Exercise and Normal physical activity in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 6 Sep 2019. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipose tissue expandability (time frame: baseline). The study lists 2 primary outcomes in all. 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 6 Sep 2019.