A Cold Physical Treatment to Manage Insulin Resistance

Obesity Clinical Trial

— CTPMIR  

Official title:

A Cold Physical Treatment to Manage Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852759
• Other study ID #: XJTU1AF-CRS-2016-018
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2019

Study information

• Verified date: April 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia
• Hyperinsulinemia
• Hyperinsulinism
• Insulin Resistance
• Obesity

Intervention

Procedure:
• Selective 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.

Device:
• Electroacupuncture
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Columbia University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of serum insulin levels	8 weeks will be compared to 0 week	0, 8 week
Secondary	Change of Body weight	8 weeks will be compared to 0 week	0, 8 week
Secondary	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
Secondary	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