Health TrialsbyHealthPanel

Electro-Acupuncture for Obese Patients With Insulin Resistance

ConditionsObesityInsulin Resistance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorNanyang Technological University

About this trial

This clinical trial aims to evaluate the efficacy and safety of electro-acupuncture for obese patients with insulin resistance. 60 participants will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women aged between 21 and 65 years old

BMI ≥ 25 kg/m2

HOMA-IR ≥ 2.14, (HOMA-IR = fasting insulin (ųU/mL)* fasting glucose (mmol/L)/22.5)

Not receiving any other weight control measures or any medical and/or drug history in the last 3 months

Disqualifiers

Diabetes mellitus

Treating with drugs that may affect insulin sensitivity

Changes 10% of usual body weight in the previous 6 months weight

Endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture needles

    Device

    The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Electroacupuncture groupExperimental treatment 1 intervention
Group B: Sham acupuncture groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

delta HOMA-IR

delta HOMA-IR = (end-of-treatment fasting insulin (ųU/mL)\* end-of-treatment fasting glucose (mmol/L)/22.5) - (baseline fasting insulin (ųU/mL)\* baseline fasting glucose (mmol/L)/22.5)

Time frame
From baseline to the end of treatment at week 8

Secondary outcomes

1

Body Mass Index (BMI)

BMI = kg/m2

Time frame
From enrollment to the end of follow-up at week 16
2

Waist-to-hip ratio

The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips.

Time frame
From baseline to the end of follow-up at week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanyang Technological University

Lead sponsor

Source ClinicalTrials.gov
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