Clinical trial NCT06359418: Acupuncture for Obesity With Prediabetes
Official title: Acupuncture for Obese Adults With Prediabetes: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Pre-diabetes
Keywords: acupuncture
randomized controlled trial
Obesity
Pre-diabetes
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Hubei Hospital of Traditional Chinese Medicine
name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: Dongfang Hospital Beijing University of Chinese Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Heilongjiang Academy of traditional Chinese Medicine
First posted: 2024-04-11
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes.


Eligibility criteria: Inclusion Criteria:

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Subjects are eligible to be included in the trial only if all of the following criteria apply:

1. Meet the diagnostic criteria of obesity and pre-diabetes;
2. Aged 18-64 years old;
3. Informed consent obtained before any trial-related activities.

Exclusion Criteria:

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Subjects are excluded from the trial if any of the following criteria apply:

1. Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
2. impaired glucose regulation due to hyperthyroidism, endocrine tumors and extensive liver damage;
3. Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator;
4. Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), antidepressants, antipsychotic, mood stabilizers, antiepileptic and hormone contraceptive;
5. History of pancreatitis or pancreatectomy;
6. Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
7. Current participation (or within the last month) in an organized weight reduction program or currently using or used medication for obesity or hyperglycemia within 3 months before screening: liraglutide, exenatide, pramlintide, orlistat, topiramate, phenteremine, or metformin (either by prescription or as part of a clinical trial);
8. A self-reported change in body weight \>5 kg within 3 months before screening irrespective of medical records;
9. Serious medical conditions (including but not limited to ongoing renal or hepatic insufficiency, congestive heart failure, myocardial infarction, stroke, hematopoietic system diseases, progressive malignant tumor or other serious consumptive diseases); history of angina pectoris, transient ischemic attack, claudication, or acute limb ischemia within the past 6 months prior to screening;
10. Serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, and anorexia nervosa; current serious personality disorder, (e.g. borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt or current active suicidal ideation, recent hospitalization due to psychiatric illness;
11. Skin infection, blood coagulation disorders and other conditions that are not suitable for acupuncture;
12. Metal allergies or severe fear of needles;
13. Pregnant or breast-feeding women or planning to become pregnant during the study period;
14. Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

Primary outcomes:
measure: The percentage change in body weight from baseline to week 12
timeFrame: week 12
Secondary outcomes:
measure: The percentage change in body weight compared to the baseline
timeFrame: week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36
measure: Achievement of a reduction in body weight of 5% or more compared to the baseline
timeFrame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36
measure: Achievement of a reduction in body weight of 7% or more compared to the baseline
timeFrame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36
measure: The change in 1hPG from baseline and percentage of patients who returned to normal
timeFrame: week 12, week 36
measure: The change in 2hPG from baseline and percentage of patients who returned to normal
timeFrame: week 12, week 36
measure: The change in FPG from baseline and percentage of patients who returned to normal
timeFrame: week 12, week 36
measure: The change in HbA1c from baseline and percentage of patients who returned to normal
timeFrame: week 12, week 36
measure: The change in waist circumference from baseline
timeFrame: week 4, week 8, week 12, week 16, week 24, week 36
measure: The change in BMI from baseline
timeFrame: week 4, week 8, week 12, week 16, week 24, week 36
measure: The change in WHR from baseline
timeFrame: week 4, week 8, week 12, week 16, week 24, week 36
measure: The change in WHtR from baseline
timeFrame: week 4, week 8, week 12, week 16, week 24, week 36
measure: The change in blood pressure from baseline
timeFrame: week 4, week 8, week 12, week 16, week 24, week 36
measure: Changes in appetite VAS score from baseline
timeFrame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36
measure: The change in FINS from baseline
timeFrame: week 12, week 36
measure: The change in HOMA-IR from baseline
timeFrame: week 12, week 36
measure: The change in HOMA-β from baseline
timeFrame: week 12, week 36
measure: The change in Serum total cholesterol from baseline
timeFrame: week 12, week 36
measure: The change in Triglyceride from baseline
timeFrame: week 12, week 36
measure: The change in Low-Density Lipoprotein Cholesterol from baseline
timeFrame: week 12, week 36
measure: The change in High-Density Lipoprotein Cholesterol from baseline
timeFrame: week 12, week 36
measure: The change in Serum Uric Acid from baseline
timeFrame: week 12, week 36
measure: Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline.
timeFrame: week 12, week 36
measure: Changes of the PHQ-4 score from the baseline.
timeFrame: week 12, week 36
Other outcomes:
measure: Expectance assessment
timeFrame: baseline
measure: Assessment of belief in acupuncture
timeFrame: baseline
measure: Blinding assessment
timeFrame: week 12
measure: Safety assessment
timeFrame: week 0 to week 36
measure: Adherence assessment of acupuncture
timeFrame: weeks 1 to week 12
measure: Adherence assessment of life modification
timeFrame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: