Clinical trial NCT05347030: Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population
Official title: Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population: a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impaired Glucose Tolerance
Overweight
Obese
Prediabetic State
Keywords: impaired glucose tolerance
overweight
obese
Prediabetic State
acupuncture
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The trial will be conducted at three hospitals in China. 196 eligible subjects will be randomly assigned (1:1) to the acupuncture or sham acupuncture group to receive either 30-session acupuncture/sham acupuncture treatment over 12 weeks based on lifestyle intervention and 24-week follow-up. The primary outcome is the change in the value of 2-hour blood glucose (2hPG) from baseline at the end of the 12-week treatment. Additionally, compliance, blinding, and safety will also be assessed. All statistical tests will be performed using a two-sided test, a p-value of less than 0.05 is considered significant.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. 18-60 years old;
3. those who can appropriately describe their wishes, voluntarily fill in the informed consent form and agree to participate in clinical trials.

Exclusion Criteria:

1. obesity secondary to heredity, drugs, and diseases;
2. those who have received weight-loss treatment including acupuncture and drugs in the past 3 months;
3. 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;
4. IGT is caused by abnormal thyroid function, endocrine tumors, extensive liver damage;
5. abnormal glucose tolerance caused by thiazide diuretics, β-blockers, nicotinic acid drugs, quinolones, calcineurin inhibitors, interferon-alpha, etc;
6. received antidiabetic medicines in the past 3 months；
7. participants with serious primary diseases such as heart, lung, brain, liver, or hematopoietic system diseases, progressive malignant tumor, or other serious consumptive diseases;
8. Participants with cognitive impairment and severe mental illness;
9. participants with blood coagulation dysfunction, and scare of needles；
10. pregnant, breastfeeding, or planning to conceive within 37 weeks.

Primary outcomes:
measure: The change in the value of 2-hour blood glucose from baseline at the end of the 12-week treatment
timeFrame: week 12
Secondary outcomes:
measure: The change in the value of 2-hour blood glucose from baseline
timeFrame: weeks 24 and 36
measure: The proportion of participants whose 2-hour blood glucose dropped to normal from baseline
timeFrame: weeks 12, 24 and 36
measure: The proportion of participants with at least 5% reductions in body weight from baseline
timeFrame: weeks 4, 8, 12, 16, 24 and 36
measure: The change from baseline of body mass index
timeFrame: weeks 4, 8, 12, 16, 24 and 36
measure: The change from baseline of fasting plasma glucose
timeFrame: weeks 12, 24 and 36
measure: The change from baseline of Fasting serum insulin
timeFrame: weeks 12, 24 and 36
measure: The change from baseline of Homeostasis model assessment-insulin resistance
timeFrame: weeks 12, 24 and 36
measure: The change from baseline of Waist-to-Hip Ratio
timeFrame: weeks 4, 8, 12, 16, 24 and 36
measure: The change from baseline in the SNAQ scores
timeFrame: weeks 4, 8, 12, 16, 24 and 36
measure: The change from baseline in the IWQOL-Lite scale scores
timeFrame: weeks 4, 8, 12, 16, 24 and 36
measure: The change from baseline of TC, TG, LDL-C, and HDL-C
timeFrame: weeks 12, 24 and 36
measure: The change from baseline of blood pressure
timeFrame: weeks 12, 24 and 36
Other outcomes:
measure: Expectation assessment
timeFrame: baseline
measure: Blinding assessment
timeFrame: week 12
measure: Compliance assessment of acupuncture
timeFrame: week 12
measure: Compliance assessment of life modification
timeFrame: weeks 4, 8, 12, 16, 24 and 36
measure: Incidence of Adverse Events
timeFrame: week 0 to 36
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Yan Yan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.