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ObesityPhase 4NCT03571802

Pharmacokinetics of Simvastatin Post Laparoscopic Sleeve Gastrectomy (LSG)

A Phase 4 study testing Simvastatin in people with Obesity and Hyperlipidemias, run by National University Hospital, Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to investigate the change in systemic exposure of simvastatin post LSG. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Obesity, Hyperlipidemias
What is being tested?
Simvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSingapore
Study dates
13 Jun 2018to 30 Jun 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Planned for laparoscopic sleeve gastrectomy at National University Hospital
  • Taking statin
  • Aged 21 or above

Who cannot join

  • Patient on concomitant treatment with medications/ food/ herbal supplements that may affect the pharmacokinetics of simvastatin: boceprevir, conivaptan, cyclosporine, efavirenz, mitotane, tocilizumab, rifamycin, amiodarone, amlodipine, aprepitant, azithromycin, colchicine, fenofibrate, imatinib, raltegravir, ranolazine, teriflunomide, ticagrelor, fusidic acid, protease inhibitors, telaprevir, telithromycin, gemfibrozil, erythromycin, clarithromycin, carbamazepine, rifampicin, ketoconazole, fluconazole, itraconazole, voriconanzole, diltiazem, verapamil, dexamethasone, prednisolone, phenytoin, ritonavir, indinavir, nelfinavir, bosentan, telithromycin, nefazodone, St John's wort, orlistat, sibutramine and other strong CYP 3A4 inhibitors/ inducers
  • Pregnant ladies

Trial locations and contacts

1 site in 1 country.

Asim Shabbir, MBBS contact

+65 9820 0814

cfsasim@nuhs.edu.sg

Elaine Lo, PharmD contact

+65 9877 2682

elaine_lo@nuhs.edu.sg

Singapore1 site, 1 recruiting

  • National University Hospital

    Singapore, 119228

    Asim Shabbir, MBBS, +65 9820 0814, cfsasim@nus.edu.sg

    Elaine Lo, PharmD, +65 9877 2682, elaine_lo@nuhs.edu.sg

    Recruiting

Other trials in Singapore

About this study

Official title: The Need of Dosing Adjustment for Simvastatin in Obese Patients Post Bariatric Surgery- Laparoscopic Sleeve Gastrectomy (LSG)

This study aims to investigate the change in systemic exposure of simvastatin post LSG.

Read the detailed description

Morbid obesity (Body mass index > 40 kg/m2 or 35-39 kg/m2 with comorbidity; 37.5 kg/m2 for Asians) is a growing global health issue. Bariatric surgery is the only intervention that has demonstrated sustainable reduction in weight and comorbidities.1,2 Among the various bariatric procedures, laparoscopic sleeve gastrectomy (LSG) has rapidly gained popularity worldwide.3,4 Physiological alterations following LSG include reduction in gastrointestinal surface and reduced retention of food. Bioavailability of drugs may be affected but published literature in this area is sparse and studies are usually small and uncontrolled.5-7 Moreover, some reports concerning gastric banding and jejunoileal bypass are no longer practiced because of the associated risk. In general, bioavailability of orally administered drug changes with a reduction in gastrointestinal area. While Kroll et al showed slight increase in area under curve of rivaroxaban post bariatric surgery8, Skottheim et al demonstrated significant but variable change in systemic exposure of atorvastatin after gastric bypass (from threefold decrease to twofold increase) that diminished but was sustained with time (21-45 months post gastric bypass)9-10.

No study has investigated the change in pharmacokinetics of simvastatin post LSG.

Simvastatin is a widely-used lipid-lowering agent with a low bioavailability of 5% due to the extensive first pass metabolism.11 As simvastatin undergoes hydrolysis in the stomach to the active form12, it is postulated that bioavailability of simvastatin will decrease after LSG.13-15 A decrease in bioavailability may be associated with reduced efficacy. Authors of review articles suggested choosing an alternative agent to simvastatin post bariatric surgery. However, such recommendation is largely based on theoretical concern rather than solid evidence.14,15 A previous study attempted to model the pharmacokinetics of simvastatin post Roux-en-Y and biliopancreatic diversion with duodenal switch.13 The data is not applicable to LSG and the model did not take into account of the pH-dependent hydrolysis. This will be the first study aiming to investigate the change in systemic exposure of simvastatin post LSG.

Being tested
Simvastatin
Keywords
pharmacokinetics, simvastatin, bariatric surgery, laparoscopic sleeve gastrectomy
Medical subject headings
Obesity, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimvastatinDrug

    Also called Study arm

    • The subject will take simvastatin 20mg at 0 h (after stopping simvastatin for 5 days). 5 mL of blood will be sampled at 0 h, 1 h, 2 h, 3 h, 5 h, 7 h.
    • There will be 2 blood sampling sessions: 1 before and the other 3 months after surgery.
Study groups in NCT03571802
Study groupRoleWhat they receive
intervention armExperimentalsimvastatin 20mg once
Receives: Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under Curve (AUC) of simvastatin

    Ratio of AUC of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

    Measured: baseline (before surgery). 3 months after surgery

  2. Maximum serum concentration (Cmax) of simvastatin

    Ratio of Cmax of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

    Measured: baseline (before surgery). 3 months after surgery

  3. Time at which maximum serum concentration (Tmax) of simvastatin

    Ratio of Tmax of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

    Measured: baseline (before surgery). 3 months after surgery

  4. Area Under Curve (AUC) of simvastatin acid

    Ratio of AUC of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

    Measured: baseline (before surgery). 3 months after surgery

  5. Maximum serum concentration (Cmax) of simvastatin acid

    Ratio of Cmax of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

    Measured: baseline (before surgery). 3 months after surgery

  6. Time at which maximum serum concentration (Tmax) of simvastatin acid

    Ratio of Tmax of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported

    Measured: baseline (before surgery). 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2018
  2. Study start13 Jun 2018
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pharmacokinetic parameters of simvastatin before and after laparoscopic sleeve gastrectomy will be compared in 10 patients. Each patient will serve as their own control for comparison.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571802
Sponsor's protocol ID
LSGSIMVASTATIN
Status last verified
Apr 2022
First submitted
22 May 2018
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No plan to share IPD

Publications

  • Skottheim IB, Stormark K, Christensen H, Jakobsen GS, Hjelmesaeth J, Jenssen T, Reubsaet JL, Sandbu R, Asberg A. Significantly altered systemic exposure to atorvastatin acid following gastric bypass surgery in morbidly obese patients. Clin Pharmacol Ther. 2009 Sep;86(3):311-8. doi: 10.1038/clpt.2009.82. Epub 2009 Jun 3.

    PubMed 19494810

  • Jakobsen GS, Skottheim IB, Sandbu R, Christensen H, Roislien J, Asberg A, Hjelmesaeth J. Long-term effects of gastric bypass and duodenal switch on systemic exposure of atorvastatin. Surg Endosc. 2013 Jun;27(6):2094-101. doi: 10.1007/s00464-012-2716-3. Epub 2012 Dec 18.

    PubMed 23247745

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Simvastatin in people with Obesity and Hyperlipidemias, run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Asim Shabbir, MBBS (+65 9820 0814, cfsasim@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under Curve (AUC) of simvastatin (time frame: baseline (before surgery). 3 months after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03571802, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

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