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Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

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ClinicalTrials.gov Identifier: NCT03986008
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
The purpose of this studay is to evaluate the effects of Benaglutide on the treatment of subjects with obesity.

Condition or disease Intervention/treatment Phase
Obesity Drug: Benaglutide Drug: Liraglutide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : May 23, 2021
Estimated Study Completion Date : May 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Benaglutide
Benaglutide will be administered three times a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given 10 minutes before each meal.
Drug: Benaglutide
The treatment of Benaglutide lasted three months.During the first week: 0.1mg per day;During the second week: 0.14mg per day; From third week onwards, 0.2mg per day.
Other Name: rhGLP-1(7-36)

Active Comparator: Liraglutide
Liraglutide will be administered once a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given independently of meals and preferably at the same each day.
Drug: Liraglutide
The treatment of Liraglutide lasted three months.During the first week: 0.6mg per day;During the second week: 1.2mg per day; From third week onwards, 1.8mg per day.
Other Name: Victoza




Primary Outcome Measures :
  1. Weight Change at 3 months [ Time Frame: baseline and 3 months ]
    Measured in kilograms

  2. Gut microbiota composition [ Time Frame: 3 months ]
    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).


Secondary Outcome Measures :
  1. Change in waist circumference [ Time Frame: baseline and 3 months ]
    Measured in cm

  2. Change in systolic blood pressure [ Time Frame: baseline and 3 months ]
    Measured in mmHg

  3. Change in diastolic blood pressure [ Time Frame: baseline and 3 months ]
    Measured in mmHg

  4. Change in HbA1c [ Time Frame: baseline and 3 months ]
    Measured in %

  5. Change in plasma glucose [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  6. Change in insulin [ Time Frame: baseline and 3 months ]
    Measured in μU/ml

  7. Change in lipids-total cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  8. Change in lipids-low density lipoprotein cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  9. Change in lipids-high density lipoprotein cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  10. Change in lipids-triglycerides [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  11. Change in lipids-free fatty acids [ Time Frame: baseline and 3 months ]
    Measured in μmol/l

  12. Change in Uric Acid [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  13. Change in interleukin-10 [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  14. Change in tumor necrosis factor [ Time Frame: baseline and 3 months ]
    Measured in mmol/l



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986008


Contacts
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Contact: Jing Wu +8613574120508 wujing0731@163.com

Locations
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China, Hunan
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Jing Wu    +86-13574120508    wujing0731@163.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Jing Wu Xiangya Hospital of Central South University

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03986008     History of Changes
Other Study ID Numbers: 2019050125
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists