Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population

NCT05347030 | Unknown

• 1 other identifier: 2021-021-KY-01
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, parallel-group, participants- and assessors-blinded randomized trial aiming to evaluate the effectiveness and safety of acupuncture in improving glucose metabolism for overweight/obese Participants with IGT, in comparison with sham acupuncture.

Conditions

Impaired Glucose Tolerance; Overweight; Obese; Prediabetic State

Keywords

impaired glucose tolerance; overweight; obese; Prediabetic State; acupuncture; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The change in the value of 2-hour blood glucose from baseline at the end of the 12-week treatment

  The 2-hour blood glucose is the value of intravenous plasma glucose measured by oral 75g glucose tolerance test, which is usually used to diagnose impaired glucose tolerance and observe glucose metabolism.

  week 12

Secondary Outcomes (12)

• The change in the value of 2-hour blood glucose from baseline

  weeks 24 and 36

• The proportion of participants whose 2-hour blood glucose dropped to normal from baseline

  weeks 12, 24 and 36

• The proportion of participants with at least 5% reductions in body weight from baseline

  weeks 4, 8, 12, 16, 24 and 36

• The change from baseline of body mass index

  weeks 4, 8, 12, 16, 24 and 36

• The change from baseline of fasting plasma glucose

  weeks 12, 24 and 36

Other Outcomes (5)

• Expectation assessment

  baseline

• Blinding assessment

  week 12

• Compliance assessment of acupuncture

  week 12

Study Arms (2)

Acupuncture Group

EXPERIMENTAL

The acupuncture points are: EX-B3, BL18, BL20, BL21, GV20, GV29, LI11, CV12, CV10, ST25, CV6, CV4, ST40, SP6. After piercing 15-35mm into the skin, the needles will be gently rotated and lifted three times to achieve a sense of sourness, distention, and heaviness (de qi). For EX-B3, BL18, BL20, and BL21, withdrawn afterward immediately. For GV20, GV29, LI11, CV12, CV10, ST25, CV6, CV4, ST40 and SP6, The needles will be maintained for 30 minutes.

Other: Acupuncture

Sham Acupuncture Group

SHAM COMPARATOR

sham acupoints are located at a horizontal distance of 20 mm to those points used in the acupuncture group, and no manipulation was carried out after piercing the skin for 1-2mm to avoid de-qi sensation. For sham EX-B3, BL18, BL20, and BL21, withdraw immediately after piercing. For sham GV20, GV29, LI11, CV12, CV10, ST25, CV6, CV4, ST40 and SP6, The needles will be maintained for 30 minutes after puncture.

Other: Sham Acupuncture

Interventions

Acupuncture OTHER

During the 12-week treatment, acupuncture will be administrated 3 times a week (once every other day) in the first 6 weeks, and twice a week in the last 6 weeks (with an interval of 2-3 days). Each treatment session will last 30 minutes.

Acupuncture Group

Sham Acupuncture OTHER

During the 12-week treatment, Sham Acupuncture will be administrated 3 times a week (once every other day) in the first 6 weeks, and twice a week in the last 6 weeks (with an interval of 2-3 days). Each treatment session will last 30 minutes.

Sham Acupuncture Group

Eligibility Criteria

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

You may qualify if:

• those who meet the diagnostic criteria of overweight/obesity and IGT:
• ①IGT: fasting blood glucose (PG) is lower than 7.0mmol/L, and 2-hour blood glucose (2hPG) after oral 75g glucose tolerance test (OGTT) is between 7.8\~11.1mmol/L.
• ②overweight: 24.0 \< BMI ≤ 27.9, obesity: BMI ≥ 28.0, or BMI ≤24.0 but Waist Circumference ≥85 cm (male) /≥80 cm(female).
• years old;
• those who can appropriately describe their wishes, voluntarily fill in the informed consent form and agree to participate in clinical trials.

You may not qualify if:

• obesity secondary to heredity, drugs, and diseases;
• those who have received weight-loss treatment including acupuncture and drugs in the past 3 months;
• those who have taken drugs that have known effects on body weight or appetite in the past 3 months, such as corticosteroids, antidepressants, non-selective antihistamines in vivo, nicotine substitutes, etc;
• IGT is caused by abnormal thyroid function, endocrine tumors, extensive liver damage;
• abnormal glucose tolerance caused by thiazide diuretics, β-blockers, nicotinic acid drugs, quinolones, calcineurin inhibitors, interferon-alpha, etc;
• received antidiabetic medicines in the past 3 months；
• participants with serious primary diseases such as heart, lung, brain, liver, or hematopoietic system diseases, progressive malignant tumor, or other serious consumptive diseases;
• Participants with cognitive impairment and severe mental illness;
• participants with blood coagulation dysfunction, and scare of needles；
• pregnant, breastfeeding, or planning to conceive within 37 weeks.

Sponsors & Collaborators

• Yan Yan: lead

Study Sites (1)

Guang'anmen Hospital

Beijing, 100053, China

RECRUITING

Related Publications (1)

• Yan Y, Sun Y, Wang X, Zhu L, Chen Y, Liu Z. Acupuncture for Impaired Glucose Tolerance in People With Obesity: A Protocol for a Multicenter Randomized Controlled Trial. Front Med (Lausanne). 2022 Jul 12;9:932102. doi: 10.3389/fmed.2022.932102. eCollection 2022.

  PMID: 35903320 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Overweight; Obesity; Prediabetic State

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yan Yan

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Yan

CONTACT

+8618579122011; yanyanxuexi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 26, 2022
• Study Start: October 6, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

CN (1)