A Cold Physical Treatment to Manage Insulin Resistance (CTPMIR)
Primary Purpose
Insulin Resistance, Hyperglycemia, Hyperinsulinemia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Selective Cold
Electroacupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance
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
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
Intensive Care group
Arm Description
Add Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance.
continue the existing management of insulin resistance in these patients. They will receive the same follow up, examinations etc as intervention group.
Outcomes
Primary Outcome Measures
Change of Glucose Tolerance measured by OGTT
glucose tolerance at 8 weeks will be compared to 0 week
Secondary Outcome Measures
Change of serum insulin levels
8 weeks will be compared to 0 week
Change of Body weight
8 weeks will be compared to 0 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
Change of glucose infusion rate by hyperinsulinemic euglycemic clamp
8 week will be compared to 0 week
Full Information
NCT ID
NCT02852759
First Posted
July 20, 2016
Last Updated
April 29, 2020
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT02852759
Brief Title
A Cold Physical Treatment to Manage Insulin Resistance
Acronym
CTPMIR
Official Title
A Cold Physical Treatment to Manage Insulin Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Columbia University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Hyperglycemia, Hyperinsulinemia, Diabetes, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Add Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance.
Arm Title
Intensive Care group
Arm Type
No Intervention
Arm Description
continue the existing management of insulin resistance in these patients. They will receive the same follow up, examinations etc as intervention group.
Intervention Type
Procedure
Intervention Name(s)
Selective Cold
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Glucose Tolerance measured by OGTT
Description
glucose tolerance at 8 weeks will be compared to 0 week
Time Frame
0, 8 week, 2 hours for each measurement
Secondary Outcome Measure Information:
Title
Change of serum insulin levels
Description
8 weeks will be compared to 0 week
Time Frame
0, 8 week
Title
Change of Body weight
Description
8 weeks will be compared to 0 week
Time Frame
0, 8 week
Title
Change of 2-deoxy-2-[fluorine-18]fluoro- D-glucose (FDG) uptake by PET/CT-scans
Description
8 week will be compared to 0 week
Time Frame
0 and 8 week, 2 hours for each measurement
Title
Change of glucose infusion rate by hyperinsulinemic euglycemic clamp
Description
8 week will be compared to 0 week
Time Frame
0 and 8 week, 5 hours for each measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Qiang, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study result will be published after finishing the trial
Learn more about this trial
A Cold Physical Treatment to Manage Insulin Resistance
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