The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients

Obesity Clinical Trial

Official title:

The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04839237
• Other study ID #: 201710832
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2021
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This studay evaluates the effect of liraglutide in the treatment of obese patients ande the influence of genetic factors on the curative effect.Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Description:

Background:The rapid growth of obese or overweight people in the world has become a major social problem. Obese often associated with kinds of metabolic disorders, especially type 2 diabetes, and Liraglutide can effectively reduce weight and improve blood glucose.Previous studies have indicated that most patients will experience different degrees of weight loss after using Liraglutide, but there is also a small number of patients with no significant weight loss.The gene polymorphism among individuals may affect the weight loss effect of Liraglutide.

Objectives：1.To find the relationships between genetic variants and the response of Liraglutide to treatment of obese patients.2.To investigate the effects of Liraglutide on weight, metabolism (blood glucose, blood lipid, uric acid, etc.) and gut microbiota in obese Chinese patients.

Intervention:Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18 to 65 years (to the date of screening);

2. The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).

3. Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.

4. Weight stable for more than 3 months (weight fluctuations <5%).

Exclusion Criteria:

1. Pregnant female.

2. Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.

3. Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.

4. Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.

5. Nearly a month had surgery, trauma, infection and so on.

6. Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.

7. Poor medication compliance or serious side effects (severe rash, syncope, etc.).

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Liraglutide
The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards,1.8mg per day, subcutaneous injection.
• Liraglutide;metformin
The treatment of Liraglutide combined with metformin lasted three months.For Liraglutide,during the first week: 0.6mg per day, subcutaneous injection;during the second week: 1.2mg per day, subcutaneous injection; from third week onwards,1.8mg per day, subcutaneous injection.For metformin,during three months:0.5g each time, 3 times per day,oral.

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change at 3 months	Measured in kilograms	baseline and 3 months
Primary	Genotype		baseline
Secondary	Change in waist circumference	Measured in cm	baseline and 3 months
Secondary	Change in systolic blood pressure	Measured in mmHg	baseline and 3 months
Secondary	Change in diastolic blood pressure	Measured in mmHg	baseline and 3 months
Secondary	Change in HbA1c	Measured in %	baseline and 3 months
Secondary	Change in plasma glucose	Measured in mmol/l	baseline and 3 months
Secondary	Change in insulin	Measured in µU/ml	baseline and 3 months
Secondary	Change in lipids-total cholesterol	Measured in mmol/l	baseline and 3 months
Secondary	Change in lipids-low density lipoprotein cholesterol	Measured in mmol/l	baseline and 3 months
Secondary	Change in lipids-high density lipoprotein cholesterol	Measured in mmol/l	baseline and 3 months
Secondary	Change in lipids-triglycerides	Measured in mmol/l	baseline and 3 months
Secondary	Change in lipids-free fatty acids	Measured in µmol/l	baseline and 3 months
Secondary	Change in Uric Acid	Measured in mmol/l	baseline and 3 months
Secondary	Gut microbiota composition	Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).	3 months