Insulin ResistanceCTPMIRNCT02852759
A Cold Physical Treatment to Manage Insulin Resistance
A study testing Selective Cold and Electroacupuncture in people with Insulin Resistance and Hyperglycemia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insulin Resistance, Hyperglycemia, Hyperinsulinemia
- What is being tested?
- Selective Cold and Electroacupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI: 20-30
- Insulin resistant
Who cannot join
- uncontrolled hypertension
- insulin dependent diabetics
- heart diseases
- hyperthyroidism
- secondary obesity
- surgical operation within treatment or planned in two months
Show all 10Show fewer
- pregnancy
- anemia
- liver or kidney failure
- cancer
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
About this study
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
- Being tested
- Selective Cold, Electroacupuncture
- Medical subject headings
- Insulin Resistance, Hyperglycemia, Hyperinsulinism, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective ColdProcedure or surgery
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.
ElectroacupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Add Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Glucose Tolerance measured by OGTT
glucose tolerance at 8 weeks will be compared to 0 week
Measured: 0, 8 week, 2 hours for each measurement
Secondary outcomes (4)
Change of serum insulin levels
8 weeks will be compared to 0 week
Measured: 0, 8 week
Change of Body weight
8 weeks will be compared to 0 week
Measured: 0, 8 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
Measured: 0 and 8 week, 2 hours for each measurement
Change of glucose infusion rate by hyperinsulinemic euglycemic clamp
8 week will be compared to 0 week
Measured: 0 and 8 week, 5 hours for each measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Li Qiang, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852759
- Sponsor's protocol ID
- XJTU1AF-CRS-2016-018
- Acronym
- CTPMIR
- Status last verified
- Apr 2020
- First submitted
- 20 Jul 2016
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Study result will be published after finishing the trial
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cold Physical Treatment to Manage Insulin Resistance
- ClinicalTrials.gov ID
- NCT02852759
- Acronym / sponsor ID
- CTPMIR / XJTU1AF-CRS-2016-018
- Conditions
- Insulin Resistance, Hyperglycemia, Hyperinsulinemia, Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: Selective Cold, Device: ElectroacupunctureAdd Selective Cold and Electroacupuncture treatment to the existing treatment for patients with insulin resistance. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI: 20-30
- Insulin resistant
Key exclusion criteria (10 listed)
- uncontrolled hypertension
- insulin dependent diabetics
- heart diseases
- hyperthyroidism
- secondary obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective ColdThe 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. | Procedure or surgery | intervention group |
| ElectroacupunctureElectroacupuncture (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. | Device | intervention group |
Primary outcome
Change of Glucose Tolerance measured by OGTT
Time frame: 0, 8 week, 2 hours for each measurement
glucose tolerance at 8 weeks will be compared to 0 week
4 secondary outcomes
Change of serum insulin levels
Time frame: 0, 8 week
Change of Body weight
Time frame: 0, 8 week
Change of 2-deoxy-2-[fluorine-18]fluoro- D-glucose (FDG) uptake by PET/CT-scans
Time frame: 0 and 8 week, 2 hours for each measurement
Change of glucose infusion rate by hyperinsulinemic euglycemic clamp
Time frame: 0 and 8 week, 5 hours for each measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: Yes. Study result will be published after finishing the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Qiang, Ph.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Cold and Electroacupuncture in people with Insulin Resistance and Hyperglycemia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Glucose Tolerance measured by OGTT (time frame: 0, 8 week, 2 hours for each measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.