Back to resultsAcupuncture for Impaired Glucose Tolerance in Overweight/Obese Population
Primary Purpose
Impaired Glucose Tolerance, Overweight, Obese
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring impaired glucose tolerance, overweight, obese, Prediabetic State, acupuncture, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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.
Sites / Locations
- Guang'anmen HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acupuncture Group
Sham Acupuncture Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
The proportion of participants with at least 5% reductions in body weight from baseline
The body weight will be reported in kg.
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.
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.
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.
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 β cell function (HOMA- β) were evaluated by fasting blood glucose value (FPG) and fasting serum islet level (FINS). The calculation method is HOMA-IR=FPG × FINS/225;HOMA- β = 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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05347030
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yan Yan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance, Overweight, Obese, Prediabetic State
Keywords
impaired glucose tolerance, overweight, obese, Prediabetic State, acupuncture, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Acupuncture Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in the value of 2-hour blood glucose from baseline at the end of the 12-week treatment
Description
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.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
The change in the value of 2-hour blood glucose from baseline
Description
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.
Time Frame
weeks 24 and 36
Title
The proportion of participants whose 2-hour blood glucose dropped to normal from baseline
Description
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.
Time Frame
weeks 12, 24 and 36
Title
The proportion of participants with at least 5% reductions in body weight from baseline
Description
The body weight will be reported in kg.
Time Frame
weeks 4, 8, 12, 16, 24 and 36
Title
The change from baseline of body mass index
Description
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.
Time Frame
weeks 4, 8, 12, 16, 24 and 36
Title
The change from baseline of fasting plasma glucose
Description
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.
Time Frame
weeks 12, 24 and 36
Title
The change from baseline of Fasting serum insulin
Description
The fasting serum insulin is measured by oral 75g glucose tolerance test, which was used to diagnose impaired glucose tolerance and observe glucose metabolism.
Time Frame
weeks 12, 24 and 36
Title
The change from baseline of Homeostasis model assessment-insulin resistance
Description
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 β cell function (HOMA- β) were evaluated by fasting blood glucose value (FPG) and fasting serum islet level (FINS). The calculation method is HOMA-IR=FPG × FINS/225;HOMA- β = 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.
Time Frame
weeks 12, 24 and 36
Title
The change from baseline of Waist-to-Hip Ratio
Description
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.
Time Frame
weeks 4, 8, 12, 16, 24 and 36
Title
The change from baseline in the SNAQ scores
Description
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.
Time Frame
weeks 4, 8, 12, 16, 24 and 36
Title
The change from baseline in the IWQOL-Lite scale scores
Description
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.
Time Frame
weeks 4, 8, 12, 16, 24 and 36
Title
The change from baseline of TC, TG, LDL-C, and HDL-C
Description
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.
Time Frame
weeks 12, 24 and 36
Title
The change from baseline of blood pressure
Description
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.
Time Frame
weeks 12, 24 and 36
Other Pre-specified Outcome Measures:
Title
Expectation assessment
Description
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".
Time Frame
baseline
Title
Blinding assessment
Description
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".
Time Frame
week 12
Title
Compliance assessment of acupuncture
Description
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%).
Time Frame
week 12
Title
Compliance assessment of life modification
Description
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.
Time Frame
weeks 4, 8, 12, 16, 24 and 36
Title
Incidence of Adverse Events
Description
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.
Time Frame
week 0 to 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Yan
Phone
+8618579122011
Email
yanyanxuexi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Yan
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Yan
Phone
+8618579122011
Email
yanyanxuexi@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35903320
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.
Results Reference
derived
Learn more about this trial
Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population
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