Analysis of the Influence of Gastric By-Pass on the Pharmacokinetics of Common Drugs

NCT06460896 | Not Yet Recruiting

• 1 other identifier: APHP230873
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Lack of knowledge of digestive absorption of drugs used in metabolic syndrome (MS) before and after gastric by-pass (GBP) in obese patients. The main objective is to study the changes in apparent clearance of candesartan, amlodipine, metformin and rosuvastatin, used in the treatment of metabolic syndrome in obese patients, between the preoperative period and 1 and 6 months after the performance of a GBP.

Conditions

Bypass Bariatric Surgery

Keywords

bypass bariatric surgery, metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• The main objective is to study the changes in apparent clearance of candesartan, amlodipine, metformin and rosuvastatin, used in the treatment of metabolic syndrome in obese patients

  Difference in apparent clearance of study drugs between preoperative and postoperative phases at 1 month after surgery

  preoperative and postoperative phases at 1 month after surgery

Secondary Outcomes (7)

• Determine changes in apparent clearance at 6 months after gastric bypass surgery compared with the pre-operative phase

  pre-operative phase and 1 and 6 months after surgery

• Explain changes in apparent clearance as a function of weight loss

  pre-operative phase and 1 and 6 months after surgery

• Explain changes in apparent clearance as a function of changes in the fat/lean mass ratio

  pre-operative phase and 1 and 6 months after surgery

• Determine changes in apparent volumes of distribution between the pre-operative phase and 1 and 6 months after surgery

  pre-operative phase and 1 and 6 months after surgery

• Explain changes in apparent volumes of distribution as a function of body weight loss

  pre-operative phase and 1 and 6 months after surgery

Study Arms (1)

Patients eligible for bypass bariatric surgery and treated for metabolic syndrome

OTHER

6 samples will be taken on the same day (T0, i.e. just before taking the drug, then T30 minutes, T1h, T2h, T4h, T7h after taking the drug).

Other: pharmacokinetic study

Interventions

pharmacokinetic study OTHER

Multicenter pharmacokinetic study of the bioavailability of four compounds in GBP patients: candesartan, amlodipine, metformin and rosuvastatin.

Patients eligible for bypass bariatric surgery and treated for metabolic syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients having undergone a complete bariatric course, eligible for bariatric surgery after validation of the operative indication by a multidisciplinary RCP dedicated to obesity, in accordance with HAS criteria: morbid obesity with BMI \> 40 kg/m2 or severe obesity with BMI \>35Kg/m2
• Patients with a comorbidity linked to one of the elements of metabolic syndrome that can be improved by surgery: type 2 diabetes, hypertension, dyslipidemia.
• Patients treated pre-operatively for at least 2 weeks with one or more of the molecules designed to control metabolic syndrome and selected for our study:
• Antihypertensive: amlodipine; candesartan,
• Hypolipidemic: rosuvastatin
• Hypoglycemic agent: metformin
• Patients scheduled for Y-shaped gastric bypass surgery
• Membership of a social security scheme

You may not qualify if:

• History of restrictive bariatric surgery (sleeve)
• History of renal or hepatocellular insufficiency
• Patient undergoing treatment or having stopped treatment within the last month with a drug that may alter the clearance of the molecules studied: enzyme inducer or inhibitor (boosted antiproteases, macrolides, azole antifungals, grapefruit juice, rifampicin, rifabutin, phenobarbital, phenytoin, St John's wort), probenecid, non-steroidal anti-inflammatory drugs, etc.
• Patients treated with a drug that may alter the bioavailability of associated drugs: antacids containing aluminium or magnesium hydroxide, gastric dressings, etc.
• Patients for whom it is impossible to give informed consent (language barrier)
• Patients taking part in another interventional clinical study
• Patients under legal protection (guardianship, curatorship)
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de chirurgie digestive, bariatrique et endocrinienne

Bobigny, 93000, France

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrea LAZZATI

  Assistance Publique de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea LAZZATI

CONTACT

06 67 47 66 03; andrea.lazzati@aphp.fr

Vicent JULLIEN, Pr

CONTACT

01 48 02 62 28; vincent.jullien@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 14, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 14, 2024

Record last verified: 2024-05

Locations

FR (1)