Back to resultsChronic Intermittent Cold Exposure on Weight Loss (CICE)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole body cryotherapy
counseling and behavioral therapy for weight loss
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Weight loss, brown adipose tissue, white adipose tissue, muscle, metabolism, cold exposure
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional weight loss treatment group
Cryo group
Arm Description
Eating and physical activity counseling and behavioral therapy for weight loss.
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
Outcomes
Primary Outcome Measures
weight loss
Effect of chronic intermittent cold exposure and conventional treatment on weight loss
Secondary Outcome Measures
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).
energy metabolism
Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism
behavioural patterns
Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns
muscle metabolism
Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism
white adipose tissue metabolism
Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism
Full Information
NCT ID
NCT01312090
First Posted
March 7, 2011
Last Updated
September 5, 2012
Sponsor
Helsinki University Central Hospital
Collaborators
Turku University Hospital, Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT01312090
Brief Title
Chronic Intermittent Cold Exposure on Weight Loss
Acronym
CICE
Official Title
Chronic Intermittent Cold Exposure on Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Turku University Hospital, Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To test whether chronic intermittent cold exposure is more effective in programmed body weight loss when compared to conventional programmed weight loss.
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
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
To measure tissue specific biochemical indicators before and after treatment with chronic intermittent cold exposure from white adipose tissue and skeletal muscle.
To compare changes in body composition and fat distribution after weight loss using chronic cold exposure or using conventional method
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss, brown adipose tissue, white adipose tissue, muscle, metabolism, cold exposure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional weight loss treatment group
Arm Type
Active Comparator
Arm Description
Eating and physical activity counseling and behavioral therapy for weight loss.
Arm Title
Cryo group
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
Whole body cryotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
counseling and behavioral therapy for weight loss
Intervention Description
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 Outcome Measure Information:
Title
weight loss
Description
Effect of chronic intermittent cold exposure and conventional treatment on weight loss
Time Frame
looking forward using periodic observations collected predominantly during 12 months following subject enrollment
Secondary Outcome Measure Information:
Title
Glucose uptake
Description
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).
Time Frame
4 months from admission
Title
energy metabolism
Description
Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism
Time Frame
12 months from admission
Title
behavioural patterns
Description
Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns
Time Frame
12 months from admission
Title
muscle metabolism
Description
Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism
Time Frame
12 months from admission
Title
white adipose tissue metabolism
Description
Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism
Time Frame
12 months from admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsi H Pietilainen, MD, PhD
Organizational Affiliation
Obesity research Unit, Department of Medicine, Helsinki University Central Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33560372
Citation
van der Kolk BW, Muniandy M, Kaminska D, Alvarez M, Ko A, Miao Z, Valsesia A, Langin D, Vaittinen M, Paakkonen M, Jokinen R, Kaye S, Heinonen S, Virtanen KA, Andersson DP, Mannisto V, Saris WH, Astrup A, Ryden M, Blaak EE, Pajukanta P, Pihlajamaki J, Pietilainen KH. Differential Mitochondrial Gene Expression in Adipose Tissue Following Weight Loss Induced by Diet or Bariatric Surgery. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1312-1324. doi: 10.1210/clinem/dgab072.
Results Reference
derived
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Chronic Intermittent Cold Exposure on Weight Loss
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