Chronic Intermittent Cold Exposure on Weight Loss (CICE)

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: counseling and behavioral therapy for weight loss; Biological: Whole body cryotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01312090

PS09RUSRAS

T1070RUSRA (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Conventional weight loss treatment group

Active Comparator group

Description:

Eating and physical activity counseling and behavioral therapy for weight loss.

Treatment:

Behavioral: counseling and behavioral therapy for weight loss

Cryo group

Experimental group

Description:

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

Treatment:

Biological: Whole body cryotherapy