A Cold Physical Treatment to Manage Insulin Resistance

Not Applicable

Completed

• Conditions: Obesity; Diabetes; Insulin Resistance; Hyperglycemia; Hyperinsulinemia
• Interventions: Procedure: Selective Cold; Device: Electroacupuncture

• Registration Number: NCT02852759
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2018-10
• Study Completion: 2019-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Selective Cold	Add Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance.
intervention group	Electroacupuncture	Add Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 glucose infusion rate by hyperinsulinemic euglycemic clamp	0 and 8 week, 5 hours for each measurement	8 week will be compared to 0 week

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China