NCT02106039

Brief Summary

The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis- diabetes patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
3 countries

3 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

First Submitted

Initial submission to the registry

March 19, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

April 28, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

April 18, 2019

Status Verified

September 1, 2017

Enrollment Period

2.8 years

First QC Date

March 19, 2014

Last Update Submit

April 17, 2019

Conditions

Diabetes MellitusPulmonary Tuberculosis

Keywords

diabetes mellitustuberculosismanagementrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Better diabetes control in diabetes patients with tuberculosis under treatment

    Diabetes control is determined by HbA1c level (unit: %) which will be measured at month 3 and 6 of TB treatment.

    Up to 6 months during TB treatment

Secondary Outcomes (3)

  • Cost-effectiveness of different strategies for diabetes management during TB treatment

    Up to 6 months

  • Measurement of long-term requirements for diabetes management in TB patients diagnosed with diabetes after TB treatment completed

    12 months after completing TB treatment

  • Association between glycemic control and clinical-microbiological response to TB treatment

    up to 6 months

Study Arms (2)

intensive monitoring

EXPERIMENTAL

more intensive monitoring strategy of blood glucose and clinical review

Procedure: intensive monitoring

standard monitoring

NO INTERVENTION

glucose monitoring followed the prevailing practice at each site

Interventions

intensive monitoringPROCEDURE
intensive monitoring

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult (\> 18 years old) diabetes mellitus patients
  • diagnosed as having active pulmonary TB
  • willing to join the study

You may not qualify if:

  • under TB treatment more than 72 hours
  • steroid-induced or gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Faculty of Medicine, Universitas Padjadjaran

Bandung, West Java, 40161, Indonesia

Location

Universidad Peruana Cayetano Heredia

Lima, San Martin de Porres, 31, Peru

Location

University of Medicine and Pharmacy Craiova

Bucharest, Romania

Location

Related Publications (13)

  • Baker MA, Harries AD, Jeon CY, Hart JE, Kapur A, Lonnroth K, Ottmani SE, Goonesekera SD, Murray MB. The impact of diabetes on tuberculosis treatment outcomes: a systematic review. BMC Med. 2011 Jul 1;9:81. doi: 10.1186/1741-7015-9-81.

    PMID: 21722362BACKGROUND

  • Ruslami R, Aarnoutse RE, Alisjahbana B, van der Ven AJ, van Crevel R. Implications of the global increase of diabetes for tuberculosis control and patient care. Trop Med Int Health. 2010 Nov;15(11):1289-99. doi: 10.1111/j.1365-3156.2010.02625.x.

    PMID: 20955495BACKGROUND

  • Bidstrup TB, Stilling N, Damkier P, Scharling B, Thomsen MS, Brosen K. Rifampicin seems to act as both an inducer and an inhibitor of the metabolism of repaglinide. Eur J Clin Pharmacol. 2004 Apr;60(2):109-14. doi: 10.1007/s00228-004-0746-z. Epub 2004 Mar 19.

    PMID: 15034704BACKGROUND

  • Hatorp V, Hansen KT, Thomsen MS. Influence of drugs interacting with CYP3A4 on the pharmacokinetics, pharmacodynamics, and safety of the prandial glucose regulator repaglinide. J Clin Pharmacol. 2003 Jun;43(6):649-60.

    PMID: 12817528BACKGROUND

  • Jaakkola T, Backman JT, Neuvonen M, Laitila J, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics of pioglitazone. Br J Clin Pharmacol. 2006 Jan;61(1):70-8. doi: 10.1111/j.1365-2125.2005.02515.x.

    PMID: 16390353BACKGROUND

  • Niemi M, Backman JT, Neuvonen M, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of nateglinide in healthy subjects. Br J Clin Pharmacol. 2003 Oct;56(4):427-32. doi: 10.1046/j.1365-2125.2003.01884.x.

    PMID: 12968988BACKGROUND

  • Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivisto KT. Rifampin decreases the plasma concentrations and effects of repaglinide. Clin Pharmacol Ther. 2000 Nov;68(5):495-500. doi: 10.1067/mcp.2000.111183.

    PMID: 11103752BACKGROUND

  • Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivisto KT. Effects of rifampin on the pharmacokinetics and pharmacodynamics of glyburide and glipizide. Clin Pharmacol Ther. 2001 Jun;69(6):400-6. doi: 10.1067/mcp.2001.115822.

    PMID: 11406737BACKGROUND

  • Niemi M, Kivisto KT, Backman JT, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of glimepiride. Br J Clin Pharmacol. 2000 Dec;50(6):591-5. doi: 10.1046/j.1365-2125.2000.00295.x.

    PMID: 11136298BACKGROUND

  • Park JY, Kim KA, Kang MH, Kim SL, Shin JG. Effect of rifampin on the pharmacokinetics of rosiglitazone in healthy subjects. Clin Pharmacol Ther. 2004 Mar;75(3):157-62. doi: 10.1016/j.clpt.2003.10.003.

    PMID: 15001966BACKGROUND

  • Park JY, Kim KA, Park PW, Park CW, Shin JG. Effect of rifampin on the pharmacokinetics and pharmacodynamics of gliclazide. Clin Pharmacol Ther. 2003 Oct;74(4):334-40. doi: 10.1016/S0009-9236(03)00221-2.

    PMID: 14534520BACKGROUND

  • Syvalahti E, Pihlajamaki K, Iisalo E. Effect of tuberculostatic agents on the response of serum growth hormone and immunoreactive insulin to intravenous tolbutamide, and on the half-life of tolbutamide. Int J Clin Pharmacol Biopharm. 1976 Mar;13(2):83-9.

    PMID: 1254383BACKGROUND

  • Zilly W, Breimer DD, Richter E. Induction of drug metabolism in man after rifampicin treatment measured by increased hexobarbital and tolbutamide clearance. Eur J Clin Pharmacol. 1975 Dec 19;9(2-3):219-27. doi: 10.1007/BF00614021.

    PMID: 1233266BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes MellitusTuberculosis, PulmonaryTuberculosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hazel Dockrell, Prof

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Reinout van Crevel, MD, PhD

    Radboud Universisty Nijmegen Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

April 7, 2014

Study Start

April 28, 2014

Primary Completion

February 21, 2017

Study Completion

December 21, 2017

Last Updated

April 18, 2019

Record last verified: 2017-09

Locations

PE(1)RO(1)ID(1)