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| Name | Class |
|---|---|
| National Institute of Biological Sciences, Beijing | UNKNOWN |
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This is a randomized, controlled, double blind clinical trial. The purpose of this study is to investigate the weight loss efficacy of entacapone. In this study, participants are randomly divided into entacapone and placebo groups. The percentage change in body weight, the body mass index, waist circumstance, extent of fatty liver, quantity of visceral fat, serum insulin, serum triglyceride and the adverse effects are compared between the two groups.
All volunteers should clearly understand the objectives and the risks of the present study. Then, all volunteers should carefully read and sign the informed consent and receive a copy of the signed informed consent. If the volunteer agrees to participate to the present study and signs the informed consent, the volunteer is included. The included participants should be followed up and the case report form should be competed by appointed researchers.
Recruiting stage:
To check whether a volunteer are eligible to participate:
Grouping stage:
A group of 12 Participants enter the study at a time,
Intervening stage:
Two weeks after the first intervention, monthly telephone interview start:
1.1 Ask the participant the details of taking medicine, following the diet and exercise regime, the present body weight; 1.2 Ask the participant whether they have any discomfort and to decide whether medical interventions are needed.
Four weeks after the first intervention, monthly hospital interview start:
2.1 The day before the participants go to hospital for the second interview. 2.1.1 Any drink, food and strenuous activity should be avoided at least 8 hours before the second interview; 2.1.2 The standard form of daily activity should be brought. 2.2 During this interview: 2.2.1 Physical examination:blood pressure, heart rate, height, bodyweight, waist and hip circumference; 2.2.2 The details of participants taking medicine, following the diet and exercise regime should be asked; 2.2.3 Laboratory examination: level of adiponectin, leptin, resistin, C-reactive protin, insulin, fasting blood glucose, haemoglobin A1c, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol; 2.2.4 20ml blood sample is collected to measure the level of adiponectin, resistin, leptin and the expression of obese related genes; 2.2.5 Abdominal MRI should be made; 2.2.6 Any discomfort of the participants should be recorded and medical treatment should be provided when it is necessary; 2.2.7 The previous standard form of daily activity are hand over to the CRA and blank forms are provided; 2.2.8 The untaken drugs should be retrieved, packed and a record should be maed; 2.2.9 Drugs of the next month should be distributed and a relevant record should be made.
2.3 Participate go back home. 2.3.1 Participants continue to take entacapone or placebo as the physicians and researchers have instructed and make a record in a standard form; 2.3.2 Participants continue to carry out the diet and exercise regime, measure their bodyweight everyday and take a record.
All the data should be recorded in a standard case report form and the accuracy, completeness and timeliness be regularly checked by an appointed clinical research associate.
The sample size is calculated by the software PASS 11.0. The alternative hypothesis set as Mean 1\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| entacapone | Experimental | An approach of 200mg entacapone at a time and 4 times a day(0.5 hour after every breakfast, lunch and supper and at 0.5 hours before bedtime) is adopted. Every participant is required to record his/her diet, exercise, and drug intake condition in a standard record card which is provided by the researchers. |
|
| placebo | Placebo Comparator | Except for taking the placebo rather than the entacapone, any intervention in the placebo group is the same with that in the entacapone group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entacapone | Drug | 200 mg entacapone, oral intake, 4 times per day (after breakfast, lunch, supper and before sleep at night), for 6 six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in bodyweight | The final result will be assessed six months after intervention | Monthly until the 6th month after the 1st intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body mass index | Monthly until the 6th month after the 1st intervention | |
| Waist circumstance | Monthly until the 6th month after the 1st intervention | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaichun Wu, PhD., MD. | Contact | 86-29-84771502 | kaicwu@fmmu.edu.cn | |
| Shiqi Wang, MD. | Contact | 86-29-84771533 | wsqfmmu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Kaichun Wu, MD, PhD | Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C071192 | entacapone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Placebo | Drug | 200 mg placebo, oral intake, 4 times per day (after breakfast, lunch, supper and before sleep at night), for 6 six months |
|
|
| Visceral adipose tissue |
| Monthly until the 6th month after the 1st intervention |
| Serum adipokines | level of adiponectin, leptin, resistin, C-reactive protein | Monthly until the 6th month after the 1st intervention |
| glucose tolerance index | insulin, fasting blood glucose, haemoglobin A1c | Monthly until the 6th month after the 1st intervention |
| Dyslipidemia index | triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol | Monthly until the 6th month after the 1st intervention |
| Adverse effects | pain, fatigue, back pain, sweating increased, dyskinesias, dizziness, nausea, diarrhea, abdominal pain, constipation, mouth dry, hallucination, upper respiratory tract infection, fall, urine abnormal | Monthly until the 6th month after the 1st intervention |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |