NCT01086722

Brief Summary

Morbid obesity (MO) is associated with several disorders such as hypertension, type 2 diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment. Drug bioavailability and metabolism in patients with MO is altered compared to population controls. Bariatric surgery is the gold standard treatment for MO when conventional therapy fails. Bariatric surgery techniques can modify drug absorption in MO patients. These modifications depend on the drug absorption characteristics and on the bariatric surgery technique used. The changes in weight and body composition caused by BS at middle term can alter drug bioavailability and metabolism. The kinetics of the "normalization" process in patients with MO after bariatric surgery is unknown Objectives. To analyze the changes in drug metabolism and pharmacokinetics. To establish drug dosing criteria in the post-intervention period in patients with MO after bariatric surgery. To determine the relationship between changes in drug bioavailability and metabolism in MO after bariatric surgery (longitudinal gastrectomy and Y-roux gastric by-pass).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

3 years

First QC Date

March 3, 2010

Last Update Submit

October 14, 2015

Conditions

Morbid ObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Metabolic ratios of probe substances

    Metabolic ratios of parent drugs and metabolites in plasma and urine before and after bariatric surgery.

    8 hours after drug administration

Secondary Outcomes (1)

  • Pharmacokinetics of probe substances

    0-8 hours

Study Arms (1)

"karolinska cocktail"

EXPERIMENTAL

The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol

Drug: "karolinska cocktail"

Interventions

"karolinska cocktail"DRUG

The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol

"karolinska cocktail"

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults (from 18 to 55 years)
  • Morbid Obesity BMI \> 40 or BMI\> 35 plus co-morbidity
  • Healthy controls (non-overweight and overweight groups)

You may not qualify if:

  • Allergy to study drugs
  • Liver diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

IMIM-Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (1)

  • Goday Arno A, Farre M, Rodriguez-Morato J, Ramon JM, Perez-Mana C, Papaseit E, Civit E, Langohr K, Li Carbo M, Boix DB, Nino OC, Le Roux JAF, Pera M, Grande L, de la Torre R. Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques on Paracetamol and Caffeine Metabolism. Obes Surg. 2017 Dec;27(12):3194-3201. doi: 10.1007/s11695-017-2745-z.

    PMID: 28560524DERIVED

MeSH Terms

Conditions

Obesity, MorbidOverweight

Condition Hierarchy (Ancestors)

ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Albert Goday, MD

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 15, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

ES(2)