Diabetes, Hyperglycemia, Hyperinsulinemia, Insulin Resistance, Obesity
Conditions
Brief summary
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.
Interventions
PROCEDURESelective Cold
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.
DEVICEElectroacupuncture
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.
Sponsors
Columbia University
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Glucose Tolerance measured by OGTT | 0, 8 week, 2 hours for each measurement | glucose tolerance at 8 weeks will be compared to 0 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum insulin levels | 0, 8 week | 8 weeks will be compared to 0 week |
| Change of Body weight | 0, 8 week | 8 weeks will be compared to 0 week |
| Change of 2-deoxy-2-[fluorine-18]fluoro- D-glucose (FDG) uptake by PET/CT-scans | 0 and 8 week, 2 hours for each measurement | 8 week will be compared to 0 week |
| Change of glucose infusion rate by hyperinsulinemic euglycemic clamp | 0 and 8 week, 5 hours for each measurement | 8 week will be compared to 0 week |
Countries
China
Outcome results
None listed