Chronic Intermittent Cold Exposure on Weight Loss (CICE)

• ClinicalTrials.gov Identifier: NCT01312090
• Recruitment Status: Completed
• First Posted: March 10, 2011
• Last Update Posted: September 6, 2012
• Sponsor: Helsinki University Central Hospital
• Collaborators: Turku University Hospital; Novo Nordisk A/S
• Information provided by (Responsible Party): Sanna Kaye, Helsinki University Central Hospital

Study Description

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

Condition or disease	Intervention/treatment	Phase
Obesity	Biological: Whole body cryotherapy; Behavioral: counseling and behavioral therapy for weight loss	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Chronic Intermittent Cold Exposure on Weight Loss
• Study Start Date: October 2010
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Conventional weight loss treatment group; Eating and physical activity counseling and behavioral therapy for weight loss.	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).
Experimental: Cryo group; 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	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.

Outcome Measures

Primary Outcome Measures :

1. weight loss [ Time Frame: 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 :

1. Glucose uptake [ Time Frame: 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).
2. energy metabolism [ Time Frame: 12 months from admission ]
   Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism
3. behavioural patterns [ Time Frame: 12 months from admission ]
   Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns
4. muscle metabolism [ Time Frame: 12 months from admission ]
   Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism
5. white adipose tissue metabolism [ Time Frame: 12 months from admission ]
   Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Helsinki University Central Hospital

Turku University Hospital

Novo Nordisk A/S

Investigators

• Principal Investigator: Kirsi H Pietilainen, MD, PhD; Obesity research Unit, Department of Medicine, Helsinki University Central Hospital

More Information

• Responsible Party: Sanna Kaye, MD, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT01312090
• Other Study ID Numbers: PS09RUSRAS; T1070RUSRA ( Other Identifier: Helsinki University Central Hospital registry )
• First Posted: March 10, 2011
• Last Update Posted: September 6, 2012
• Last Verified: September 2012

Keywords provided by Sanna Kaye, Helsinki University Central Hospital:

Weight loss; brown adipose tissue; white adipose tissue; muscle, metabolism; cold exposure

Additional relevant MeSH terms:

Weight Loss; Body Weight Changes; Body Weight