Status:
UNKNOWN
Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population
Lead Sponsor:
Yan Yan
Conditions:
Impaired Glucose Tolerance
Overweight
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
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/sha...
Eligibility Criteria
Inclusion
- 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).
- 18-60 years old;
- those who can appropriately describe their wishes, voluntarily fill in the informed consent form and agree to participate in clinical trials.
Exclusion
- 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.
Key Trial Info
Start Date :
October 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT05347030
Start Date
October 6 2022
End Date
December 31 2024
Last Update
February 23 2023
Active Locations (1)
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1
Guang'anmen Hospital
Beijing, China, 100053