Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population

Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population: a Multi-center Randomized Controlled Trial

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.

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.

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.