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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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Rigshospitalet

Status

Completed

Conditions

Type 2 Diabetes Mellitus
Insulin Resistance
Dyslipidemia

Treatments

Behavioral: Exercise
Dietary Supplement: High carbohydrate overfeeding
Behavioral: Normal physical activity

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02982408
H-4-2014-128

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

Male

Ages

35 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Low birth weight (LBW)
Experimental group
Description:
25 males born at term (weeks 39-41) in 1979-1981 with LBW (BW\<10th percentile)
Treatment:
Dietary Supplement: High carbohydrate overfeeding
Behavioral: Exercise
Behavioral: Normal physical activity
Normal birth weight (NBW)
Experimental group
Description:
25 BMI- and age-matched males born at term (weeks 39-41) with normal birth weight (NBW) control individuals (BW: 50-90th percentile)
Treatment:
Dietary Supplement: High carbohydrate overfeeding
Behavioral: Exercise
Behavioral: Normal physical activity

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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