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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
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

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

First Posted
July 20, 2016
Last Updated
April 29, 2020
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Columbia University
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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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