Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347030
• Other study ID #: 2021-021-KY-01
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Yan Yan
• Phone: +8618579122011
• Email: yanyanxuexi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. those who meet the diagnostic criteria of overweight/obesity and IGT:

?IGT: 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.

?overweight: 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, ß-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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• Obese
• Overweight
• Prediabetic State

Intervention

Other:
• Acupuncture
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.
• Sham Acupuncture
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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yan Yan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expectation assessment	Participants will be asked "Do you think acupuncture will be effective for treating the illness?" and "Do you think acupuncture will be effective for controlling weight and improving glucose?" The response options will be "Ineffective", "the effect is not good", "uncertain", "has some effect", or "very effective".	baseline
Other	Blinding assessment	Participants will be told that insertion is deeper in traditional acupuncture group and shallower in modern acupuncture group. After treatments finished, they will be asked "Do you think you have received traditional acupuncture in the past weeks?", the answers are "Yes", "No" or "Unclear".	week 12
Other	Compliance assessment of acupuncture	compliance = (the times the Participant has received acupuncture/ the total times the Participant should receive acupuncture ) × 100% the criterion of good compliance was that the Participants had received more than 80% of treatment (including 80%).	week 12
Other	Compliance assessment of life modification	The patient's lifestyle adjustment diary card, dietary change table, dietary compliance questionnaire, and exercise compliance scale were selected to evaluate the compliance of life modification.	weeks 4, 8, 12, 16, 24 and 36
Other	Incidence of Adverse Events	Acupuncture-related adverse events(such as broken needles, hematoma, infection, etc.) and other unexpected adverse events(such as colds, falls, etc.), including their severity and possible relationship with interventions, will be recorded in detail in the patient-recorded adverse event table and the evaluator-recorded adverse event table throughout the study period. The incidence of adverse events in the two groups will be calculated at the end of the study.	week 0 to 36
Primary	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	The change in the value of 2-hour blood glucose from baseline	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.	weeks 24 and 36
Secondary	The proportion of participants whose 2-hour blood glucose dropped to normal from baseline	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.	weeks 12, 24 and 36
Secondary	The proportion of participants with at least 5% reductions in body weight from baseline	The body weight will be reported in kg.	weeks 4, 8, 12, 16, 24 and 36
Secondary	The change from baseline of body mass index	The body mass index is a figure obtained by dividing body weight by the square of height, in kilograms per meter^2. It is a universal indicator used in the world to measure the degree of obesity.	weeks 4, 8, 12, 16, 24 and 36
Secondary	The change from baseline of fasting plasma glucose	The fasting plasma glucose is measured by oral 75g glucose tolerance test, which is usually used to diagnose impaired glucose tolerance and observe glucose metabolism.	weeks 12, 24 and 36
Secondary	The change from baseline of Fasting serum insulin	The fasting serum insulin is measured by oral 75g glucose tolerance test, which was used to diagnose impaired glucose tolerance and observe glucose metabolism.	weeks 12, 24 and 36
Secondary	The change from baseline of Homeostasis model assessment-insulin resistance	Homeostasis model assessment-insulin resistance index (HOMA-IR): a mathematical model reflecting the interaction of glucose and insulin in different organs (including pancreas, liver, and surrounding tissues). It was first proposed by Matthews in 1985. Insulin resistance (HOMA-R) and islet ß cell function (HOMA- ß) were evaluated by fasting blood glucose value (FPG) and fasting serum islet level (FINS). The calculation method is HOMA-IR=FPG × FINS/225;HOMA- ß = 20 × FINS/ (FPG-3.5). The FPG unit is mmol/L, FINS µ U/ml, and the coefficient 225is the correction factor, which refers to the blood glucose level of 5 µ U / ml plasma insulin corresponding to 45mmol/L in normal/ideal individuals.	weeks 12, 24 and 36
Secondary	The change from baseline of Waist-to-Hip Ratio	Waist-to-Hip Ratio(WHR): the ratio of waist to hip circumference. It is an important measure for the diagnosis of central adiposity.; To measure waist circumference, locate the upper hip bone and the top of the right iliac crest. Place a measuring tape in a horizontal plane around the abdomen at the level of the iliac crest. To measure hip circumference, place the measuring tape on the horizontal plane and place it at the maximum extension of the hip.; Before reading the tape measure, ensure that the tape is snug, but does not compress the skin, and is parallel to the floor. The measurement is made at the end of a normal expiration.	weeks 4, 8, 12, 16, 24 and 36
Secondary	The change from baseline in the SNAQ scores	SNAQ=simple appetite questionnaire. SNAQ is a short and simple appetite assessment tool that can predict weight loss in adults. It measures the amount of food per meal, the number of meals per day, and the taste of the food. It consists of four items, each with five grades, with the total score ranging from 4 to 20 points. Lower scores indicate deterioration in appetite.	weeks 4, 8, 12, 16, 24 and 36
Secondary	The change from baseline in the IWQOL-Lite scale scores	IWQOL-Lite=Impact of Weight on Quality Of Life. IWQOL-Lite is an international scale used to measure an individual's health-related quality of life. A total of 31 questions are divided into five subscales: 11 questions concerning physical function, 7 concerning self-esteem, 4 concerning sex life, 5 concerning public pressure, and 4 concerning work. The score of each question is divided into five grades, with 5 representing always, 4 often, 3 sometimes, 2 rarely and 1 never. The total score of the questionnaire is 155, with a higher score indicating a worse quality of life.	weeks 4, 8, 12, 16, 24 and 36
Secondary	The change from baseline of TC, TG, LDL-C, and HDL-C	TC=Serum total cholesterol, TG=triglyceride, LDL-C=Low-Density Lipoprotein Cholesterol, HDL-C=High-Density Lipoprotein Cholesterol. They are important indicators to evaluate the metabolism of blood lipids in the human body, all of which will be reported in mmol/L.	weeks 12, 24 and 36
Secondary	The change from baseline of blood pressure	The blood pressure is measured by an OMRON upper arm blood pressure electronic sphygmomanometer. Before blood pressure measurement, subjects are required to sit still for five minutes, relax the whole body and take three slow deep breaths; during blood pressure measurement, subjects must keep their wrists still and placed at the same level as the heart. Keep calm and do not speak during the measurement. The blood pressure was measured 2 times and the average blood pressure was taken as the actual blood pressure.	weeks 12, 24 and 36