Obesity
Conditions
Keywords
Weight loss, brown adipose tissue, white adipose tissue, muscle, metabolism, cold exposure
Brief summary
1. To test whether chronic intermittent cold exposure is more effective in programmed body weight loss when compared to conventional programmed weight loss. 2. To measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle and circulating markers) of treatment with chronic intermittent cold exposure and conventional treatment 3. To measure tissue specific changes of weight loss and the treatment with chronic intermittent cold exposure in glucose uptake rate in adipose organ (white and brown adipose tissue), liver, myocardium, skeletal muscle and brain 4. To measure tissue specific biochemical indicators before and after treatment with chronic intermittent cold exposure from white adipose tissue and skeletal muscle. 5. To compare changes in body composition and fat distribution after weight loss using chronic cold exposure or using conventional method
Interventions
BIOLOGICALWhole body cryotherapy
Cryotherapy: The whole-cody cryotherapy device (Univers Cryo-Combi;Oy MJG Univers Ab, Helsinki, Finland) consists of 3 chambers set at different temperatures. The first 2 chambers are meant for precooling (-30°Cand-60°C), and the patient remains in these for a very short time. The third chamber temperature reaches -110°C, and the patient remains inside for 3-4 minutes wearing a bathing suit or trunks, acral parts covered.
BEHAVIORALcounseling and behavioral therapy for weight loss
Weight loss intervention with Very Low Calory Diet (VLCD, 500-1000 kcal / d + dietary supplements) and group and individual treatment (eating, physical activity counseling and behavioural therapy).
Sponsors
Turku University Hospital
Novo Nordisk A/S
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* BMI \> 30 (inclusive) * Body weight less than 120 kg * Weight stability for 3 months * Plasma triglyceride concentration less than 3.0 mmol/l * Plasma HDL-cholesterol more than 0.9 mmol/l in males and more than 1.0 mmol/l in females * Blood pressure less than 140/90 mmHg (inclusive) * Normal glucose tolerance or impaired glucose tolerance but not diabetes (fasting glucose \< 7.0 mmol/l or 2 h glucose in the oral glucose tolerance test \< 11.1 mmol/l)
Exclusion criteria
* Smoking * Frequent weight loss attempts * Pregnancy or lactation * Diabetes mellitus * Hypo/hyperthyreosis * Cardiovascular disease, stroke or neurological disorder * Medication (antihypertensive and antidiabetic drugs, lipid lowering drugs, antidepressants, corticosteroids) * Claustrophobia * Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results. * Presence of any ferromagnetic objects that would make MRI imaging contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight loss | looking forward using periodic observations collected predominantly during 12 months following subject enrollment | Effect of chronic intermittent cold exposure and conventional treatment on weight loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose uptake | 4 months from admission | Effect of chronic intermittent cold exposure and conventional treatment on glucose uptake of brown and white adipose tissue, liver, myocardium, skeletal muscle and brain (PET-scan). |
| energy metabolism | 12 months from admission | Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism |
| behavioural patterns | 12 months from admission | Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns |
| muscle metabolism | 12 months from admission | Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism |
| white adipose tissue metabolism | 12 months from admission | Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism |
Outcome results
None listed