CTPMIR: A Cold Physical Treatment to Manage Insulin Resistance

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Completed

CT.gov ID

NCT02852759

Collaborator

Columbia University (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Hyperglycemia Hyperinsulinemia Diabetes Obesity	Procedure: Selective Cold Device: Electroacupuncture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Cold Physical Treatment to Manage Insulin Resistance

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: intervention group

Add Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance.

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.

No Intervention: Intensive Care group

continue the existing management of insulin resistance in these patients. They will receive the same follow up, examinations etc as intervention group.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China	710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University
Columbia University

Investigators

Principal Investigator: Li Qiang, Ph.D., Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT02852759

Other Study ID Numbers:

XJTU1AF-CRS-2016-018

First Posted:

Aug 2, 2016

Last Update Posted:

Apr 30, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Insulin Resistance

Hyperglycemia

Hyperinsulinism

Study Results

No Results Posted as of Apr 30, 2020