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The efficacy and safety of Oxytocin for treatment of Simple Obesity and Type 2 Diabetes: Randomized Controlled Trial

The efficacy and safety of Oxytocin for treatment of Simple Obesity and Type 2 Diabetes: Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002884
Enrollment
Unknown
Registered
2012-12-13
Start date
2012-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simple Obesity, Obesity with type 2 diabete, Type 2 diabete without obesity

Interventions

Simple obesity treatment group:oxytocin
Simple obesity control group:placebo
Obesity with type 2 diabete treatment group:oxytocin
Obesity with type 2 diabete control group:placebo
Type 2 diabete without obesity treatment group:oxytocin
Type 2 diabete without obesity control group:Placebo

Sponsors

the Affiliated People's Hospital of Jiangsu University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Simple Obesity: 1. A body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) of 28 or more; 2. The ages of 20 and 60 years (a ratio 1:1 with male and female); 3. All patients provided written informed consent to participate in the study, and additional written informed consent was obtained before any study; 4. Willing and an ability to comply with the study protocol. Obesity with type 2 diabetes: 1. A body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) of 28 or more; 2. The ages of 20 and 60 years (male:femal=1:1); 3. Conform to the WHO criteria for the diagnosis of diabetes, and is judged as type 2 diabetes by the clinical evaluation; 4. By life-style and/or treated by metformin, the scheme is stabled at least 3 months; 5. Fasting plasma glucose >=7mmol/L and =8 mmol/L, and 7.0% and=7mmol/L and =8 mmol/L, and 7.0% and<9.0%; 6. All patients provided written informed consent to participate in the study, and additional written informed consent was obtained before any study; 7. Willing and an ability to comply with the study protocol.

Exclusion criteria

Exclusion criteria: Simple Obesity: 1. Diabetes mellitus; 2. Have rhinitis and chronic respiratory disease history; 3. Patients were allergic to the test drug; 4. Patients suffered from coronary heart disease, myocardial infarction, severe mental disorders, severe arrhythmia and other serious complications of liver, kidney and hematopoietic system (blood pressure was over 160/90mmHg; the ALT rised above 2 times of the upper limit of normal value; BUN and Cr were above the normal range.); 5. With tumour; 6. Autoimmune diseases; 7. Attended steroids whithin three moths before this study; 8. Attended the test drug whithin thirty days before this study; 9. Patients were pregnant or lactating women; 10. Drugs and/or alcohol abuse; 11. Intends to conduct other weight loss healers; 12. Unwilling to submit to test arrangement or automatically withdraw from the study. Obesity with type 2 diabetes: 1. Have rhinitis and chronic respiratory disease history; 2. Patients were allergic to the test drug; 3. Patients suffered from coronary heart disease, myocardial infarction, severe mental disorders, severe arrhythmia and other serious complications of liver, kidney and hematopoietic system (blood pressure was over 160/90mmHg; the ALT rised above 2 times of the upper limit of normal value; BUN and Cr were above the normal range.); 4. With tumour; 5. Autoimmune diseases; 6. Attended steroids whithin three moths before this study; 7. Attended the test drug whithin thirty days before this study; 8. Patients were pregnant or lactating women; 9. Drugs and/or alcohol abuse; 10. Intends to conduct other weight loss healers; 11. Unwilling to submit to test arrangement or automatically withdraw from the study. Type 2 diabetes without obesity: follow the Obesity with type 2 diabetes.

Design outcomes

Primary

MeasureTime frame
body mass index;weight;waist circumference;hip circumference;Blood glucose;glycosylated hemoglobin;insulin;Blood pressure;cholesterol;low density lipoprotein cholesterol;high density lipoprotein cholesterol;triglyceride;glutamic-oxalacetic transaminease;glutamic-pyruvic transaminase;serum creatinine;electrocardiograph;

Contacts

Public ContactChen-guang Wu
wcgzj1128@yahoo.com.cn+86 13852943288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026