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Completed

NCT Number: NCT02852759

A Cold Physical Treatment to Manage Insulin Resistance

Insulin resistant volunteers will choose to undergo an 8-week cold treatment, 2 hours per day, to selective regions of the body enriched with brown fat including neck, supraclavicular and interscapular regions) in combination with electroacupuncture (EA). Their insulin sensitivity and glucose and lipid homeostasis will be measured. The brown fat activation will be assessed by positron emission tomography and computed tomography (PET/CT)-scans and/or serum marker measurements.

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Key information

Conditions

Insulin Resistance Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperinsulinemia Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI: 20-30
  • Insulin resistant

Exclusion criteria

  • uncontrolled hypertension
  • insulin dependent diabetics
  • heart diseases
  • hyperthyroidism
  • secondary obesity
  • surgical operation within treatment or planned in two months
  • pregnancy
  • anemia
  • liver or kidney failure
  • cancer

Treatment and study plan

Selective Cold

Procedure

The volunteers of intervention group will undergo Selective Cold treatment below 10 degree celsius to neck, supraclavicular interscapular regions for 2 hours daily for 8 weeks. The electroacupuncture is conducted by commercially available device. Hyperinsulinemic euglycemic clamp, glucose tolerance test, blood parameter measurements, and PTC-CT scans will be conducted before and after the intervention. The participants will be instructed to maintain their normal behavior and calorie intake.

Electroacupuncture

Device

Electroacupuncture (EA) is an add-on treatment and it is applied when starting the cold treatment at the cold treated region to patients.The device is Huatuo SDZ-II model made by Suzhou Medical Appliance Factory, China.

Primary outcomes

  1. Change of Glucose Tolerance measured by OGTT

    Time frame: 0, 8 week, 2 hours for each measurement

    glucose tolerance at 8 weeks will be compared to 0 week

Secondary outcomes

  1. Change of serum insulin levels

    Time frame: 0, 8 week

    8 weeks will be compared to 0 week

  2. Change of Body weight

    Time frame: 0, 8 week

    8 weeks will be compared to 0 week

  3. Change of 2-deoxy-2-[fluorine-18]fluoro- D-glucose (FDG) uptake by PET/CT-scans

    Time frame: 0 and 8 week, 2 hours for each measurement

    8 week will be compared to 0 week

  4. Change of glucose infusion rate by hyperinsulinemic euglycemic clamp

    Time frame: 0 and 8 week, 5 hours for each measurement

    8 week will be compared to 0 week

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • Columbia University

Registry information

Acronym: CTPMIR

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 2, 2016
Registry last updated
Apr 30, 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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