Chronic Intermittent Cold Exposure on Weight Loss (CICE)

This study has been completed.
Sponsor:
Collaborators:
Turku University Hospital
Novo Nordisk A/S
Information provided by (Responsible Party):
Sanna Kaye, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01312090
First received: March 7, 2011
Last updated: September 5, 2012
Last verified: September 2012
  Purpose
  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 Intervention
Obesity
Biological: Whole body cryotherapy
Behavioral: counseling and behavioral therapy for weight loss

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Chronic Intermittent Cold Exposure on Weight Loss

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • weight loss [ Time Frame: looking forward using periodic observations collected predominantly during 12 months following subject enrollment ] [ Designated as safety issue: No ]
    Effect of chronic intermittent cold exposure and conventional treatment on weight loss


Secondary Outcome Measures:
  • Glucose uptake [ Time Frame: 4 months from admission ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism

  • behavioural patterns [ Time Frame: 12 months from admission ] [ Designated as safety issue: No ]
    Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns

  • muscle metabolism [ Time Frame: 12 months from admission ] [ Designated as safety issue: No ]
    Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism

  • white adipose tissue metabolism [ Time Frame: 12 months from admission ] [ Designated as safety issue: No ]
    Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism


Enrollment: 20
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312090

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

No publications provided

Responsible Party: Sanna Kaye, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01312090     History of Changes
Other Study ID Numbers: PS09RUSRAS, T1070RUSRA
Study First Received: March 7, 2011
Last Updated: September 5, 2012
Health Authority: Finland: Ethics Committee
Finland: Ministry of Social Affairs and Health

Keywords provided by Helsinki University Central Hospital:
Weight loss
brown adipose tissue
white adipose tissue
muscle, metabolism
cold exposure

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 29, 2014