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Completed

NCT Number: NCT04287153

Cryotherapy and Body Slimming

The purpose of this study is to evaluate the efficacy of cryotherapy on the slimming of subcutaneous fat mass in the abdomen and saddlebags. Cryotherapy is a completely non-invasive method that induces a selective reduction of fat cells by localized and controlled cooling in areas such as the abdomen, flanks, inner knees, inner thighs, back and arms.

Adipose tissue is composed of two types of tissue: white and brown adipose tissue. Studies have shown that exposure to cold induces an increase in the number of brown adipocytes (detected by PET/CT-scan) under the effect of the hormone irisin produced by the muscles. In addition, another study has shown that prolonged exposure to cold reduces the size of brown adipocytes leading to thermogenesis, suggesting that cold exposure may contribute to the control of obesity.

The freezing technology of this cryotherapy unit allows the temperature of the subcutaneous adipose tissue to move almost instantaneously from -6°C to -10°C, gradually causing the reduction of subcutaneous adipose tissue.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cryoesthetic

Paris, 75007, France

About this study

Prospective, monocentric pilot and comparative (before and after) study in simple blind (assessor different from the operator).

  • The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the level of the saddlebags.
  • Measurement of subcutaneous fat mass with iDXA scanner on treated areas
  • Metabolic parameters from a blood test: Liver function (AST, ALT, gamma GT), inflammatory markers, plasmatic fatty acids, glycerol, total cholesterol, triglycerides, lipids, blood sugar, insulin, lactate.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients ≥ 18 years old and non-menopausal with a BMI between 20 and 30 (20≥IMC≤30), with an overload of abdominal subcutaneous fat tissue and at the saddlebags

Exclusion criteria

  • - < 18 years old.
  • Pregnancy
  • Breastfeeding
  • Cold allergy: 2-minute ice cube test positive
  • A waist/hip ratio indicative of a pathological fat distribution (>0.8 for women, >0.9 for men)
  • Endocrine pathologies (Cushing's disease, endocrine tumours, unbalanced frank or labile hypothyroidism, hirsutism and hyper-androgenism, insulin resistance and/or unbalanced type 2 diabetes...)
  • Neoplasia
  • Psychiatric pathologies with or without treatment (Antidepressants, Neuroleptics, Anxiolytics...), well characterized anorexia-bulimia syndromes.
  • Established alcoholism. Daily alcohol consumption should not exceed 2 glasses of wine per day.
  • Digestive pathologies (especially hepatic) and functional digestive disorders (chronic constipation, alternating constipation-diarrhoea, chronic abdominal pain).
  • Weaknesses of the abdominal wall (umbilical, inguinal, crural hernias)
  • HIV in therapy
  • Genetic deformities and diseases
  • Vegetarian/vegetarian diet, macrobiotic diet
  • Spasmophilia
  • Surgery less than 3 months old
  • Unbalanced coronary artery disease, untreated angina

Treatment and study plan

Cryotherapy on abdomen and saddlebags

Device

Application of variable temperature (-10°c to -7°c) on the treated areas using the cryotherapy device FG660L-006 (Beijing ADSS Development CO., Ltd)

Primary outcomes

  1. Metric measurements of the treated areas (cm)

    Time frame: 15 days after treatment

    The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the horse's breeches.

  2. Metric measurements of the treated areas (cm)

    Time frame: 3 months after treatment

    The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the horse's breeches.

Secondary outcomes

  1. iDXA scanner measurement

    Time frame: 15 days

    Measurement of subcutaneous fat mass in areas treated with the iDXA scanner

  2. iDXA scanner measurement

    Time frame: 3 months

    Measurement of subcutaneous fat mass in areas treated with the iDXA scanner

  3. Metabolic assessment

    Time frame: 15 days after treatment

    Metabolic assessment from a blood test: Liver function: Transaminase GOT, Transaminase GPT, Gamma GT (U/l)

  4. Metabolic assessment

    Time frame: 15 days after treatment

    Total cholesterol, triglycerides, HDL cholesterol (g/l)

  5. Metabolic assessment

    Time frame: 15 days after treatment

    Neopterin (nmol/l)

  6. Metabolic assessment

    Time frame: 15 days after treatment

    leptin (pg/l)

  7. Metabolic assessment

    Time frame: 15 days after treatment

    adipoleptin (mg/l)

Sponsors and collaborators

Lead sponsor

Clinic Cryo Esthetic

Industry

Registry information

Official study title

Evaluation of the Effectiveness of Cryotherapy in Slimming of the Abdomen and Saddlebags

Acronym: Cryotherapy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2020
Registry last updated
Feb 27, 2020

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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