Clinical trial NCT01312090: Chronic Intermittent Cold Exposure on Weight Loss
Official title: Chronic Intermittent Cold Exposure on Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight loss
brown adipose tissue
white adipose tissue
muscle, metabolism
cold exposure
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Novo Nordisk A/S
First posted: 2011-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: weight loss
timeFrame: looking forward using periodic observations collected predominantly during 12 months following subject enrollment
Secondary outcomes:
measure: Glucose uptake
timeFrame: 4 months from admission
measure: energy metabolism
timeFrame: 12 months from admission
measure: behavioural patterns
timeFrame: 12 months from admission
measure: muscle metabolism
timeFrame: 12 months from admission
measure: white adipose tissue metabolism
timeFrame: 12 months from admission
Other outcomes:
Locations:
Study officials:
affiliation: Obesity research Unit, Department of Medicine, Helsinki University Central Hospital
name: Kirsi H Pietilainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.