A Cold Physical Treatment to Manage Insulin Resistance

NCT ID: NCT02852759

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance Hyperglycemia Hyperinsulinemia Diabetes Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention group

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

Group Type EXPERIMENTAL

Selective Cold

Intervention Type 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.

Electroacupuncture

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Qiang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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XJTU1AF-CRS-2016-018

Identifier Type: -

Identifier Source: org_study_id

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