Chronic Intermittent Cold Exposure on Weight Loss

Obesity Clinical Trial

— CICE  

Official title:

Chronic Intermittent Cold Exposure on Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312090
• Other study ID #: PS09RUSRAS
• Secondary ID: T1070RUSRA
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: September 5, 2012
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Biological:
• Whole 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.

Behavioral:
• counseling 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).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Novo Nordisk A/S, Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	Effect of chronic intermittent cold exposure and conventional treatment on weight loss	looking forward using periodic observations collected predominantly during 12 months following subject enrollment	No
Secondary	Glucose uptake	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).	4 months from admission	No
Secondary	energy metabolism	Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism	12 months from admission	No
Secondary	behavioural patterns	Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns	12 months from admission	No
Secondary	muscle metabolism	Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism	12 months from admission	No
Secondary	white adipose tissue metabolism	Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism	12 months from admission	No