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Completed

NCT Number: NCT01312090

Chronic Intermittent Cold Exposure on Weight Loss

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

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole body cryotherapy

Biological

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.

counseling and behavioral therapy for weight loss

Behavioral

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Novo Nordisk A/S
  • Turku University Hospital

Registry information

Acronym: CICE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2011
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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