A Cold Physical Treatment to Manage Insulin Resistance

Study Overview
=================
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.

Official Title
-----------------
A Cold Physical Treatment to Manage Insulin Resistance

Conditions
-----------------
Insulin Resistance, Hyperglycemia, Hyperinsulinemia, Diabetes, Obesity

Intervention / Treatment
-----------------
* Procedure: Selective Cold
* Device: Electroacupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Add Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance. | Procedure: Selective Cold<br>* 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.<br>Device: Electroacupuncture<br>* 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.<br>|
| No Intervention: Intensive Care group<br>continue the existing management of insulin resistance in these patients. They will receive the same follow up, examinations etc as intervention group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Glucose Tolerance measured by OGTT | glucose tolerance at 8 weeks will be compared to 0 week | 0, 8 week, 2 hours for each measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum insulin levels | 8 weeks will be compared to 0 week | 0, 8 week | 
| Change of Body weight | 8 weeks will be compared to 0 week | 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 | 0 and 8 week, 2 hours for each measurement | 
| Change of glucose infusion rate by hyperinsulinemic euglycemic clamp | 8 week will be compared to 0 week | 0 and 8 week, 5 hours for each measurement |