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Study of the Cardiometabolic Effects of Obesity Pharmacotherapy

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ClinicalTrials.gov Identifier: NCT04575194
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Athens Medical Center
Information provided by (Responsible Party):
Alexandros Kokkinos, National and Kapodistrian University of Athens

Study Description
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Brief Summary:
The aim of the present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. The study will include 40 patients, who will further be divided into two treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The patients will be examined at baseline, 3 and 6 months after the treatment initiation.

Condition or disease Intervention/treatment Phase
Obesity Blood Pressure Drug: Liraglutide 6 MG/ML [Saxenda] Drug: Naltrexone-Bupropion Combination Phase 4

Detailed Description:

This is a prospective study of patients aged ≥18 years, who are overweight (BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes) or obese patients (BMI ≥ 30 kg / m2). Patients' data will be collected before starting medication (time 0) and at 3 and 6 months under treatment in the clinical practice of the selected drug, as described in the drug's package leaflet, along with a simultaneous dietary intervention and exercise. Patient groups will be comparable in age, gender and BMI.

The aim of the study is the comparison of the efficacy of liraglutide vs. naltrexone/bupropion in metabolic and cardiovascular markers.

The following parameters will be measured:

  • Weight, height, waist and hip circumference
  • 24-hour recording of blood pressure and heart rate
  • HbA1c, total cholesterol, LDL, HDL, urine albumin/creatinine ratio
  • Bioelectric impedance for determination of total and visceral fat and muscle mass Indirect calorimetry for the determination of resting metabolic rate and total energy expenditure
  • Determination of baroreflex sensitivity (BRS) and heart rate variability (HRV) to investigate the function of the autonomic nervous system
  • Blood sample test meal at 0, 30, 60, 90, 120, 150 and 180 min to determine insulin concentration and gastrointestinal hormones involved in hunger and satiety with modern indirect calorimetry to determine postprandial thermogenic analog scales (VAS)
  • Neuropathy tests
  • Assessment of quality of life with the SF-36 questionnaire and assessment of the feeling of hunger and satiety
  • Echocardiographic determination of the left systolic and telodiastolic diameter of the left ventricle, cardiac fat and the Tei index at times 0 and 6 months with medication
  • Pericardial fat
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovascular and Metabolic Effects of Drugs for the Treatment of Obesity
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Liraglutide 3 mg
Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention.
 Drug: Liraglutide 6 MG/ML [Saxenda]
3 mg of sc liraglutide daily plus lifestyle intervention
Active Comparator: Naltrexone/bupropion 32/360 mg
Patients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention.
 Drug: Naltrexone-Bupropion Combination
32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention


Outcome Measures
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Primary Outcome Measures :
  1. Changes in blood pressure [ Time Frame: 3 and 6 months ]
    Blood pressure as assessed by 24-hour recording (numerical scale)


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: 3 and 6 months ]
    Percentage of weight lost will be measured by an electronic scale (numerical scale)

  2. Changes in glycemic [ Time Frame: 3 and 6 months ]
    Measurement of HbA1c will be measured biochemically (numerical scale)

  3. Changes in lipemic profile [ Time Frame: 3 and 6 months ]
    Total cholesterol, Triglycerides, LDL-C, HDL-C will be measured biochemically (numerical scale)

  4. Percentage of visceral fat [ Time Frame: 3 and 6 months ]
    Measurement of visceral fat by bioimpedance analysis (numerical scale)

  5. Fat mass [ Time Frame: 3 and 6 months ]
    Measurement of fat mass by bioimpedance analysis (numerical scale)

  6. Fat free mass [ Time Frame: 3 and 6 months ]
    Measurement of fat free mass by bioimpedance analysis (numerical scale)

  7. Autonomic nervous system function [ Time Frame: 3 and 6 months ]
    Measurement of heart rate variability will be measured through Ewing score and Spectral analysis testing (numerical scale)

  8. Changes in meal induced thermogenesis [ Time Frame: 3 and 6 months ]
    Measurement through indirect calorimetry and assessment of changes in Resting Metabolic Rate (RMR) (numerical scale)

  9. Changes in gut hormones involved in appetite regulation [ Time Frame: 3 and 6 months ]
    Measurement in plasma before and after the intervention during a mixed meal test will be measured through ELISA kits (numerical scale)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥18 years with BMI ≥ 30 kg / m2 or BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes.

Exclusion Criteria:

  1. Presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone
  2. Bariatric surgery
  3. Diabetes type 2
  4. Active malignancy
  5. Medication that affects weight (eg corticosteroids, phenothiazines)
Contacts and Locations
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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): NCT04575194


Contacts
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Contact: Alexandros Kokkinos, MD, PhD +302132061248 rjd@otenet.gr
Contact: Georgia Argyrakopoulou, MD, PhD, MSc +306972284033 gargyrakopoulou@gmail.com

Locations
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Greece
First Department of Propaedeutic Internal Medicine Recruiting
Athens, Greece, 11527
Contact: Alexandros Kokkinos, MD, PhD    2132061248    rjd@otenet.gr   
Sponsors and Collaborators
National and Kapodistrian University of Athens
Athens Medical Center
Investigators
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Principal Investigator: Alexandros Kokkinos, MD, PhD National and Kapodistrian University of Athens
More Information
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Responsible Party: Alexandros Kokkinos, Associate Professor in Internal Medicine, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT04575194    
Other Study ID Numbers: Obesity drugs study
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
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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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liraglutide
Naltrexone
Bupropion
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypoglycemic Agents
Incretins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors