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Chronic Intermittent Cold Exposure on Weight Loss (CICE)

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

Tracking Information
First Submitted Date  ICMJE March 7, 2011
First Posted Date  ICMJE March 10, 2011
Last Update Posted Date September 6, 2012
Study Start Date  ICMJE October 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
  • 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).
  • energy metabolism [ Time Frame: 12 months from admission ]
    Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism
  • behavioural patterns [ Time Frame: 12 months from admission ]
    Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns
  • muscle metabolism [ Time Frame: 12 months from admission ]
    Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism
  • white adipose tissue metabolism [ Time Frame: 12 months from admission ]
    Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chronic Intermittent Cold Exposure on Weight Loss
Official Title  ICMJE Chronic Intermittent Cold Exposure on Weight Loss
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Active Comparator: Conventional weight loss treatment group
    Eating and physical activity counseling and behavioral therapy for weight loss.
    Intervention: Behavioral: counseling and behavioral therapy for weight loss
  • 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

    Intervention: Biological: Whole body cryotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2011)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01312090
Other Study ID Numbers  ICMJE PS09RUSRAS
T1070RUSRA ( Other Identifier: Helsinki University Central Hospital registry )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanna Kaye, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE
  • Turku University Hospital
  • Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Kirsi H Pietilainen, MD, PhD Obesity research Unit, Department of Medicine, Helsinki University Central Hospital
PRS Account Helsinki University Central Hospital
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP