A Cold Physical Treatment to Manage Insulin Resistance

NCT02852759 | Completed

• 1 other identifier: XJTU1AF-CRS-2016-018
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Hyperglycemia; Hyperinsulinemia; Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of serum insulin levels

  0, 8 week

• Change of Body weight

  0, 8 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

• Change of glucose infusion rate by hyperinsulinemic euglycemic clamp

  0 and 8 week, 5 hours for each measurement

Study Arms (2)

intervention group

EXPERIMENTAL

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

Procedure: Selective Cold; Device: Electroacupuncture

Intensive Care group

NO INTERVENTION

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

Interventions

Selective Cold 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.

intervention group

Electroacupuncture 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.

intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI: 20-30
• Insulin resistant

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Columbia University: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

MeSH Terms

Conditions

Insulin Resistance; Hyperglycemia; Hyperinsulinism; Diabetes Mellitus; Obesity

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Li Qiang, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: August 1, 2019
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)