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| Name | Class |
|---|---|
| Columbia University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Add Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance. |
|
| Intensive Care group | No Intervention | continue the existing management of insulin resistance in these patients. They will receive the same follow up, examinations etc as intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Qiang, Ph.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | 710061 | China |
Study result will be published after finishing the trial
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006943 | Hyperglycemia |
| D006946 | Hyperinsulinism |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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|
| 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. |
|
| 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 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |