A Cold Physical Treatment to Manage Insulin Resistance

First Affiliated Hospital Xi'an Jiaotong University33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insulin Resistance Hyperglycemia Hyperinsulinemia Diabetes Obesity

Selective ColdPROCEDURE

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.

ElectroacupunctureDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of Glucose Tolerance measured by OGTT

glucose tolerance at 8 weeks will be compared to 0 week

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

Secondary Outcomes

Change of serum insulin levels

8 weeks will be compared to 0 week

Time frame: 0, 8 week

Change of Body weight

8 weeks will be compared to 0 week

Time frame: 0, 8 week

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

8 week will be compared to 0 week

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

Change of glucose infusion rate by hyperinsulinemic euglycemic clamp