Impact of Overfeeding and Following Exercise Training in Individuals With and Without Increased Risk of Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus, Insulin Resistance, Dyslipidemia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High carbohydrate overfeeding
Exercise
Normal physical activity
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
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
Sites / Locations
- Rigshospitalet, Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low birth weight (LBW)
Normal birth weight (NBW)
Arm Description
25 males born at term (weeks 39-41) in 1979-1981 with LBW (BW<10th percentile)
25 BMI- and age-matched males born at term (weeks 39-41) with normal birth weight (NBW) control individuals (BW: 50-90th percentile)
Outcomes
Primary Outcome Measures
Adipose tissue expandability
Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups
Adipose tissue expandability
Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups
Secondary Outcome Measures
Glucose turnover rate
Turnover rates will be measured after a 5 hr mealtest by use isotopic tracers in the two groups
Lipid turnover rate
Turnover rates will be measured after a 5 hr mealtest by use isotopic tracers in the two groups
Epigenetics
Marks of adipose tissue, skeletal muscle stem cell and differentiated cell type genomes.
Full Information
NCT ID
NCT02982408
First Posted
August 23, 2016
Last Updated
September 3, 2019
Sponsor
Rigshospitalet, Denmark
Collaborators
Novo Nordisk A/S, Augustinus Fonden
1. Study Identification
Unique Protocol Identification Number
NCT02982408
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Novo Nordisk A/S, Augustinus Fonden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Insulin Resistance, Dyslipidemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low birth weight (LBW)
Arm Type
Experimental
Arm Description
25 males born at term (weeks 39-41) in 1979-1981 with LBW (BW<10th percentile)
Arm Title
Normal birth weight (NBW)
Arm Type
Experimental
Arm Description
25 BMI- and age-matched males born at term (weeks 39-41) with normal birth weight (NBW) control individuals (BW: 50-90th percentile)
Intervention Type
Dietary Supplement
Intervention Name(s)
High carbohydrate overfeeding
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Normal physical activity
Intervention Description
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 Measure Information:
Title
Adipose tissue expandability
Description
Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups
Time Frame
baseline
Title
Adipose tissue expandability
Description
Percent (%) subcutaneous, visceral adipose tissue and hepatic fat will be determined by MR scanning in the two groups
Time Frame
Difference between the two groups at baseline, after 4 weeks overfeeding and after 12 weeks exercise training.
Secondary Outcome Measure Information:
Title
Glucose turnover rate
Description
Turnover rates will be measured after a 5 hr mealtest by use isotopic tracers in the two groups
Time Frame
Baseline, 4 weeks overfeeding, 12 weeks training
Title
Lipid turnover rate
Description
Turnover rates will be measured after a 5 hr mealtest by use isotopic tracers in the two groups
Time Frame
Baseline, 4 weeks overfeeding, 12 weeks training
Title
Epigenetics
Description
Marks of adipose tissue, skeletal muscle stem cell and differentiated cell type genomes.
Time Frame
Baseline, 4 weeks overfeeding, 12 weeks training
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Brøns, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allan Vaag, PhD, DMsc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet, Denmark
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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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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