Clinical trial NCT04839237: The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients
Official title: The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Weight Change at 3 months
timeFrame: baseline and 3 months
measure: Genotype
timeFrame: baseline
Secondary outcomes:
measure: Change in waist circumference
timeFrame: baseline and 3 months
measure: Change in systolic blood pressure
timeFrame: baseline and 3 months
measure: Change in diastolic blood pressure
timeFrame: baseline and 3 months
measure: Change in HbA1c
timeFrame: baseline and 3 months
measure: Change in plasma glucose
timeFrame: baseline and 3 months
measure: Change in insulin
timeFrame: baseline and 3 months
measure: Change in lipids-total cholesterol
timeFrame: baseline and 3 months
measure: Change in lipids-low density lipoprotein cholesterol
timeFrame: baseline and 3 months
measure: Change in lipids-high density lipoprotein cholesterol
timeFrame: baseline and 3 months
measure: Change in lipids-triglycerides
timeFrame: baseline and 3 months
measure: Change in lipids-free fatty acids
timeFrame: baseline and 3 months
measure: Change in Uric Acid
timeFrame: baseline and 3 months
measure: Gut microbiota composition
timeFrame: 3 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: