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Impact of Overfeeding and Following Exercise Training in Individuals With and Without Increased Risk of Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02982408
Recruitment Status : Unknown
Verified December 2016 by Charlotte Brøns, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborators:
Novo Nordisk A/S
Augustinus Fonden
Information provided by (Responsible Party):
Charlotte Brøns, Rigshospitalet, Denmark

Brief 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 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Insulin Resistance Dyslipidemia Dietary Supplement: High carbohydrate overfeeding Behavioral: Exercise Behavioral: Normal physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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?
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low birth weight (LBW)
25 males born at term (weeks 39-41) in 1979-1981 with LBW (BW<10th percentile)
Dietary Supplement: High carbohydrate overfeeding

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.


Behavioral: Exercise

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.


Behavioral: Normal physical activity

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.


Experimental: Normal birth weight (NBW)
25 BMI- and age-matched males born at term (weeks 39-41) with normal birth weight (NBW) control individuals (BW: 50-90th percentile)
Dietary Supplement: High carbohydrate overfeeding

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.


Behavioral: Exercise

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.


Behavioral: Normal physical activity

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.





Primary Outcome Measures :
  1. Adipose tissue expandability [ Time Frame: baseline ]
    Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups

  2. 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


Secondary Outcome Measures :
  1. Glucose turnover rate [ Time Frame: Baseline, 4 weeks overfeeding, 12 weeks training ]
    Turnover rates will be measured after a 5 hr mealtest by use isotopic tracers in the two groups

  2. Lipid turnover rate [ Time Frame: Baseline, 4 weeks overfeeding, 12 weeks training ]
    Turnover rates will be measured after a 5 hr mealtest by use isotopic tracers in the two groups

  3. Epigenetics [ Time Frame: Baseline, 4 weeks overfeeding, 12 weeks training ]
    Marks of adipose tissue, skeletal muscle stem cell and differentiated cell type genomes.



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Ages Eligible for Study:   35 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982408


Contacts
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Contact: Charlotte Brøns, PhD +45 3545 7127 charlotte.broens@regionh.dk

Locations
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Denmark
Rigshospitalet, Denmark Recruiting
Copenhagen, Capital Region, Denmark, 2100
Contact: Charlotte Brøns, PhD    +45 3545 7127    charlotte.broens@regionh.dk   
Principal Investigator: Charlotte Brøns, Phd         
Sponsors and Collaborators
Rigshospitalet, Denmark
Novo Nordisk A/S
Augustinus Fonden
Investigators
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Principal Investigator: Charlotte Brøns, PhD Rigshospitalet, Denmark
Study Director: Allan Vaag, PhD, DMsc Rigshospitalet, Denmark

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Responsible Party: Charlotte Brøns, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02982408     History of Changes
Other Study ID Numbers: H-4-2014-128
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Lipid Metabolism Disorders