Clinical trial NCT02982408: Impact of Overfeeding and Following Exercise Training in Individuals With and Without Increased Risk of Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Insulin Resistance
Dyslipidemia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: Augustinus Fonden
First posted: 2016-12-05
Enrollment: 48
Sex: MALE
Minimum age (years): 35
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Adipose tissue expandability
timeFrame: baseline
measure: Adipose tissue expandability
timeFrame: Difference between the two groups at baseline, after 4 weeks overfeeding and after 12 weeks exercise training.
Secondary outcomes:
measure: Glucose turnover rate
timeFrame: Baseline, 4 weeks overfeeding, 12 weeks training
measure: Lipid turnover rate
timeFrame: Baseline, 4 weeks overfeeding, 12 weeks training
measure: Epigenetics
timeFrame: Baseline, 4 weeks overfeeding, 12 weeks training
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Denmark
state: Capital Region
Study officials:
affiliation: Rigshospitalet, Denmark
name: Charlotte Brøns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Allan Vaag, PhD, DMsc
role: STUDY_DIRECTOR
References: