The clinical trial aims to evaluate the efficacy and safety of acupuncture in reducing weight and waist circumference while modulating glucose and lipid metabolism in Prediabetes with Combined Obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
260
The acupuncture needle (size 0.30x40mm) will be inserted into DU20, EX-HN3 and GB8 acupoints at the depth of 15-30mm; The acupuncture needle (size 0.30x50mm or size 0.30x75mm) will be inserted into other acupoints at the depth of 40-70mm; Manipulation will be done after insertion (6 times of small amplitude and uniform twist).
The acupuncture needle (size 0.20x25mm) will be inserted into all acupoints at the depth of 2mm without any manipulation.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China
RECRUITINGThe percentage change in body weight from baseline to week 12
The weight is measured by electronic scale with an accuracy of 0.1kg.
Time frame: week 12
The percentage change in waist circumference from baseline to week 12
The waist circumference is measured by a fiberglass tape measure with an accuracy of 0.1 centimeters.
Time frame: week 12
The percentage change in body weight compared to the baseline
The weight is measured by electronic scale with an accuracy of 0.1kg.
Time frame: week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36, week 52
The percentage change in waist circumference compared to the baseline
Waist circumference measurements are accurate to 0.1cm.
Time frame: week 4, week 8, week 16, week 20, week 24, week 28, week 32, week 36, week 52
Achievement of a reduction in body weight of 5% or more compared to the baseline
A 5% reduction is the weight loss target for obese patients recommended in most guidelines.
Time frame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52
Achievement of a reduction in body weight of 7% or more compared to the baseline
A 7% reduction is a weight loss target for obese patients with other metabolic diseases recommended in most guidelines.
Time frame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52
The change in body weight from baseline
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The weight is measured by electronic scale with an accuracy of 0.1kg.
Time frame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52
The change in waist circumference from baseline
Waist circumference measurements are accurate to 0.1cm.
Time frame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52
The proportion of participants reverting to normoglycaemia
The determination is based on the results of blood glucose laboratory parameters.
Time frame: week 12, week 36, week 52
The proportion of participants developing diabetes
The determination is based on the results of blood glucose laboratory parameters.
Time frame: week 12, week 36, week 52
The change in 2hPG from baseline and percentage of patients who returned to normal
2hPG, 2-hour post-load Plasma Glucose, will be measured by oral glucose tolerance test, in mmol/L.
Time frame: week 12, week 36, week 52
The change in FPG from baseline and percentage of patients who returned to normal
FPG is fasting plasma glucose, the result will be reported in mmol/L.
Time frame: week 12, week 36, week 52
The change in HbA1c from baseline and percentage of patients who returned to normal
HbA1c is glycated haemoglobin, the result will be reported in percentage (%) units.
Time frame: week 12, week 36, week 52
The change in 1hPG from baseline and percentage of patients who returned to normal
1hPG, 1-hour post-load Plasma Glucose, will be measured by oral glucose tolerance test, in mmol/L.
Time frame: week 12, week 36, week 52
Changes in appetite VAS score from baseline
VAS=visual analogue scale; The VAS of appetite is a 100mm with two ends pointing to "none" and "difficult to control", respectively, and the subjects mark them on the online segment according to their perception. Appetite is quantitatively evaluated by measuring the distance from the left side of the segment to the marked point.
Time frame: week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 52
The change in BMI from baseline
BMI=Body Mass Index, weight and height will be combined to report BMI in kg/m\^2.
Time frame: week 4, week 8, week 12, week 16, week 24, week 36, week 52
The change in WHR from baseline
WHR=Waist-to-Hip Ratio, the ratio of waist to hip circumference, waist and hip circumference are accurate to 0.1cm.
Time frame: week 4, week 8, week 12, week 16, week 24, week 36, week 52
The change in WHtR from baseline
WHtR=waist-to-Height Ratio, the ratio of waist circumference to height. Both are in cm units, accurate to 0.1cm.
Time frame: week 4, week 8, week 12, week 16, week 24, week 36, week 52
The change in FINS from baseline
FINS is fasting insulin, the result will be reported in pmol/L.
Time frame: week 12, week 36, week 52
The change in HOMA-IR from baseline
HOMA, Homeostatic Model Assessment, is a mathematical model reflecting the interaction of glucose and insulin in different organs (including pancreas, liver, and surrounding tissues). lt was first proposed by Matthews in 1985. Insulin Resistance (HOMA-IR) will be evaluated by fasting plasma glucose (FPG) and fasting insulin (FlNS). The calculation method is HOMA-IR=FPG xFINS/22.5.
Time frame: week 12, week 36, week 52
The change in HOMA-β from baseline
HOMA, Homeostatic Model Assessment, is a mathematical model reflecting the interaction of glucose and insulin in different organs (including pancreas, liver, and surrounding tissues). lt was first proposed by Matthews in 1985. Islet β cell function (HOMA-β ) will be evaluated by fasting plasma glucose (FPG) and fasting insulin (FlNS). The calculation method is HOMA- β = 20 x FINS/ (FPG-3.5).
Time frame: week 12, week 36, week 52
The change in Serum total cholesterol from baseline
The Serum total cholesterol will be reported in mmol/L.
Time frame: week 12, week 36, week 52
The change in Triglyceride from baseline
The Triglyceride will be reported in mmol/L.
Time frame: week 12, week 36, week 52
The change in Low-Density Lipoprotein Cholesterol from baseline
The Low-Density Lipoprotein Cholesterol will be reported in mmol/L.
Time frame: week 12, week 36, week 52
The change in High-Density Lipoprotein Cholesterol from baseline
The High-Density Lipoprotein Cholesterol will be reported in mmol/L.
Time frame: week 12, week 36, week 52
The change in Serum Uric Acid from baseline
The Serum Uric Acid will be reported in μmol/L.
Time frame: week 12, week 36, week 52
The change in C-reactive protein from baseline
The C-reactive protein will be reported in mg/L.
Time frame: week 12, week 36, week 52
The change in blood pressure from baseline
Record the values of systolic blood pressure and diastolic blood pressure in mmHg.
Time frame: week 4, week 8, week 12, week 16, week 24, week 36, week 52
Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline.
EQ-5D-5L=European Quality of Life Five Dimension Five Level Scale Questionnaire. The questionnaire which is widely used to evaluate the quality of life of the general population is divided into two parts: EQ-5D health description system and EQ-VAS. The score was calculated by calculating formula according to the choices made by the subjects in the questionnaire.
Time frame: week 12, week 36
Changes of the PHQ-4 score from the baseline.
PHQ-4=patient health questionnaire-4. PHQ-4 consists of the first two items in PHQ-9 (PHQ-2) and the first two items in GAD-7 (GAD-2), including depression and anxiety. It is translated into Chinese by scholars and verified by scholars. It has good reliability and validity and is suitable for depression and anxiety screening.
Time frame: week 12, week 36