Impaired Glucose ToleranceNCT05347030
Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population
A study testing Acupuncture in people with Impaired Glucose Tolerance and Overweight, run by Yan Yan at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Impaired Glucose Tolerance, Overweight, Obese
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 6 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital
Beijing, 100053
Yan Yan, +8618579122011, yanyanxuexi@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Impaired Glucose Tolerance, Overweight, Obese, Prediabetic State
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- impaired glucose tolerance, overweight, obese, Prediabetic State, acupuncture, randomized controlled trial
- Medical subject headings
- Glucose Intolerance, Overweight, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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 AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Experimental | 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. Receives: Other: Acupuncture |
| Sham Acupuncture Group | Sham comparator | 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. Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 12
Secondary outcomes (12)
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.
Measured: weeks 24 and 36
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.
Measured: weeks 12, 24 and 36
The proportion of participants with at least 5% reductions in body weight from baseline
The body weight will be reported in kg.
Measured: weeks 4, 8, 12, 16, 24 and 36
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.
Measured: weeks 4, 8, 12, 16, 24 and 36
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.
Measured: weeks 12, 24 and 36
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.
Measured: weeks 12, 24 and 36
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.
Measured: weeks 12, 24 and 36
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.
Measured: weeks 4, 8, 12, 16, 24 and 36
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.
Measured: weeks 4, 8, 12, 16, 24 and 36
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.
Measured: weeks 4, 8, 12, 16, 24 and 36
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.
Measured: weeks 12, 24 and 36
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.
Measured: weeks 12, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start6 Oct 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Yan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Yan Yan, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347030
- Sponsor's protocol ID
- 2021-021-KY-01
- Status last verified
- Feb 2023
- First submitted
- 18 Apr 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35903320
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05347030
- Acronym / sponsor ID
- 2021-021-KY-01
- Conditions
- Impaired Glucose Tolerance, Overweight, Obese, Prediabetic State
- Keywords
- impaired glucose tolerance, overweight, obese, Prediabetic State, acupuncture, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Yan YanUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Experimental | Other: AcupunctureThe 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 Acupuncture Group | Sham comparator | Other: Sham Acupuncturesham 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureDuring 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. | Other | Acupuncture Group |
| Sham AcupunctureDuring 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. | Other | Sham Acupuncture Group |
Primary outcome
The change in the value of 2-hour blood glucose from baseline at the end of the 12-week treatment
Time frame: week 12
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.
12 secondary outcomes
The change in the value of 2-hour blood glucose from baseline
Time frame: weeks 24 and 36
The proportion of participants whose 2-hour blood glucose dropped to normal from baseline
Time frame: weeks 12, 24 and 36
The proportion of participants with at least 5% reductions in body weight from baseline
Time frame: weeks 4, 8, 12, 16, 24 and 36
The change from baseline of body mass index
Time frame: weeks 4, 8, 12, 16, 24 and 36
The change from baseline of fasting plasma glucose
Time frame: weeks 12, 24 and 36
The change from baseline of Fasting serum insulin
Time frame: weeks 12, 24 and 36
The change from baseline of Homeostasis model assessment-insulin resistance
Time frame: weeks 12, 24 and 36
The change from baseline of Waist-to-Hip Ratio
Time frame: weeks 4, 8, 12, 16, 24 and 36
The change from baseline in the SNAQ scores
Time frame: weeks 4, 8, 12, 16, 24 and 36
The change from baseline in the IWQOL-Lite scale scores
Time frame: weeks 4, 8, 12, 16, 24 and 36
The change from baseline of TC, TG, LDL-C, and HDL-C
Time frame: weeks 12, 24 and 36
The change from baseline of blood pressure
Time frame: weeks 12, 24 and 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 35903320Yan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Yan principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Impaired Glucose Tolerance and Overweight, run by Yan Yan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Yan (+8618579122011, yanyanxuexi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the value of 2-hour blood glucose from baseline at the end of the 12-week treatment (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.