Absorption of Drugs Post-Bariatric Surgery (Absorb-Azithromycin)

NCT01154569 | Completed

• 1 other identifier: 0002390
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Bariatric (obesity) surgery has become the preferred treatment option for patients with severe obesity and is increasing in popularity. It is commonly performed, with nearly 350 000 operations in the world every year. The most common type of bariatric surgery is gastric bypass, in which stomach size is reduced by 95% and the upper intestine is bypassed. Bypass of the upper intestine may lead to medication malabsorption, although this potential adverse effect has received little study. The objective of this study is to determine whether gastric bypass reduces the absorption of a azithromycin, a medication commonly prescribed first-line for infections, especially pneumonia. Patients and non-surgical controls will receive a single dose of azithromycin under highly standardized study conditions. The absorption of azithromycin will be calculated and compared between surgical and non-surgical study groups. The investigators hypothesis is that there will be a significant reduction in the absorption of azithromycin in gastric bypass patients compared to non-surgical controls. This raises the possibility that post-gastric bypass patients treated with azithromycin may fail to respond to treatment, become worse and even die. This study will have important implications for the large number of past and future gastric bypass recipients.

Conditions

Bariatric Surgery

Keywords

drug absorption; azithromycin; obesity; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Azithromycin absorption

  Area-under-the-curve azithromycin absorption from 0 to 24 hours post dose.

  Blood samples for analysis of azithromycin levels collected at 0, 0.5, 1, 1.5, 2, 3, 5, 7 and 24 hours post-dose.

Secondary Outcomes (2)

• Tmax

  instant

• Cmax

  instant

Study Arms (2)

Post Roux-en-Y gastric bypass

ACTIVE COMPARATOR

Post-bypass receiving a single dose of azithromycin

Drug: Azithromycin

Controls

ACTIVE COMPARATOR

BMI and sex matched. Have not undergone surgery

Drug: Azithromycin

Interventions

Azithromycin DRUG

500 mg single dose

Also known as: Zithromax

Controls; Post Roux-en-Y gastric bypass

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and Female
• years old
• ≥ 3 months post-RYGB surgery or a suitable control for bariatric surgery
• Able to provide written informed consent.

You may not qualify if:

• Undergone or undergoing reversal of a previous bariatric procedure which involves further resection or bypass of the intestine.
• Any major post-operative gastrointestinal complications, such as an anastomotic leak, outlet obstruction or persistent vomiting
• Currently on azithromycin therapy
• Any contraindications to azithromycin therapy such as:
• Allergy or hypersensitivity to the drug
• liver failure or baseline liver enzymes higher than 3-fold above the upper limit of normal
• end-stage renal failure (glomerular filtration rate \< 10 ml/min)
• macrolide hypersensitivity
• history of torsade de pointes or baseline QTc interval ≥ 500 ms
• acute illness
• Pregnant or nursing
• Concomitant treatment with septra, anti-HIV drugs, digoxin, disopyramide, ergotamine, dihydroergotamine, triazolam, antihistamines (terfenadine, astemizole) and theophylline is also a contraindication to enrolment because of the potential for drug interactions that would affect the blood concentrations of azithromycin or these agents.
• Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Raj Padwal, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 29, 2011

Record last verified: 2011-07

Locations

CA (1)