Chronic Intermittent Cold Exposure on Weight Loss
- Conditions
- Obesity
- Interventions
- Behavioral: counseling and behavioral therapy for weight lossBiological: Whole body cryotherapy
- Registration Number
- NCT01312090
- Lead Sponsor
- Helsinki University Central Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional weight loss treatment group counseling and behavioral therapy for weight loss Eating and physical activity counseling and behavioral therapy for weight loss. Cryo group Whole body cryotherapy Eating and physical activity counseling and behavioral therapy for weight loss will be provided to all subjects. The subjects in the cryo group will be given whole-body cryotherapy 1-3 times a week for the 4-month-treatment period
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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