Comparative Metabolomics in Diabetes Patients From Sri Lanka and Switzerland

NCT05787457 | Terminated DMC

• 2 other identifiers: KEK-203/132527
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a case-control study, where the assumed different subtypes of type 2 diabetes in people of Tamil ethnicity and Swiss origin living in Bern, Switzerland will be examined by measuring the metabolite profiles and the corresponding genetic background as well as ethnic differences in fat distribution performed by magnetic resonance imaging (MRI). The investigators aim to show that the specific metabolite profile and the fat distribution in the Tamil population is associated with the high prevalence of diabetes in this ethnicity. Fat distribution patterns are thought to determine the expression and severity of dysglycaemia. Additionally, the investigators aim to identify the key enzymes, their corresponding genes, and the respective polymorphisms relevant for these metabolic variations.

Conditions

Diabetes Mellitus, Type 2

Keywords

Native South Asian population; Migrant South Asian population; Swiss ethnicity; Tamil ethnicity; Body fat distribution; Type 2 Diabetes; Magnetic resonance imaging; Genetic predisposition; Genetic background; Metabolomics; Non-targeted mass spectrometry; Insulin resistance; Hypertriglyceridaemia; Hyperinsulinaemia

Outcome Measures

Primary Outcomes (1)

• Metabolic phenotype of type 2 diabetes mellitus across groups

  Significant metabolic changes in blood plasma of type 2 diabetic patients compared across groups as quantified by mass-spectrometric analysis

  At baseline

Secondary Outcomes (1)

• Genetic Differences

  At baseline

Study Arms (3)

Tamil natives with Diabetes Type 2

Thirty Tamil natives (15 men, 15 women), representing general Tamil diabetic cohort.

Other: Clinical examination; Other: Blood testing; Other: MRI

Swiss natives with Diabetes Type 2_matched

Thirty Swiss natives (15 men, 15 women) matching the Tamil cohort.

Other: Clinical examination; Other: Blood testing; Other: MRI

Swiss natives with Diabetes Type 2_not matched

Thirty Swiss natives (15 men, 15 women), who are not matched to the Tamil cohort, representing general Swiss diabetic cohort.

Other: Clinical examination; Other: Blood testing; Other: MRI

Interventions

Clinical examination OTHER

Swiss natives with Diabetes Type 2_matched; Swiss natives with Diabetes Type 2_not matched; Tamil natives with Diabetes Type 2

Blood testing OTHER

Swiss natives with Diabetes Type 2_matched; Swiss natives with Diabetes Type 2_not matched; Tamil natives with Diabetes Type 2

MRI OTHER

Swiss natives with Diabetes Type 2_matched; Swiss natives with Diabetes Type 2_not matched; Tamil natives with Diabetes Type 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of thirty Tamils and sixty native Swiss people with type 2 diabetes.

You may qualify if:

• Diagnosed with type 2 diabetes per WHO criteria.
• Swiss ethnicity (defined as self-reported ancestry and parents and at least 1 grandparents are from Switzerland)
• Tamil ethnicity (defined as self-reported ancestry and parents and at least 1 grandparents are from Sri Lanka, belonging to ethnic identity of Tamils, respectively)
• Age limit: 18 - 75 years

You may not qualify if:

• Subjects with type 1 diabetes, steroid-induced diabetes, gestation diabetes, or pancreoprivic diabetes.
• Subjects with pregnancy.
• Subjects with metal implant, tattoos, or claustrophobia. MRI must be feasible.
• Subjects with severe chronic diseases, e.g. malignancies, heart or renal diseases (\> stage 3).
• Subjects not able to provide informed consent.
• Enrolled in another study.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Inselspital, Berne

Bern, 3011, Switzerland

Location

Related Publications (11)

• Abate N, Carulli L, Cabo-Chan A Jr, Chandalia M, Snell PG, Grundy SM. Genetic polymorphism PC-1 K121Q and ethnic susceptibility to insulin resistance. J Clin Endocrinol Metab. 2003 Dec;88(12):5927-34. doi: 10.1210/jc.2003-030453.

  PMID: 14671192 BACKGROUND

• Barnett AH, Dixon AN, Bellary S, Hanif MW, O'hare JP, Raymond NT, Kumar S. Type 2 diabetes and cardiovascular risk in the UK south Asian community. Diabetologia. 2006 Oct;49(10):2234-46. doi: 10.1007/s00125-006-0325-1. Epub 2006 Jul 18.

  PMID: 16847701 BACKGROUND

• Ehtisham S, Crabtree N, Clark P, Shaw N, Barrett T. Ethnic differences in insulin resistance and body composition in United Kingdom adolescents. J Clin Endocrinol Metab. 2005 Jul;90(7):3963-9. doi: 10.1210/jc.2004-2001. Epub 2005 Apr 19.

  PMID: 15840754 BACKGROUND

• Illangasekera U, Nugegoda DB, Perera LS. Prevalence of diabetes mellitus and impaired glucose tolerance in a rural Sri Lankan community. Ceylon Med J. 1993 Sep;38(3):123-6.

  PMID: 7828231 BACKGROUND

• Illangasekera U, Rambodagalla S, Tennakoon S. Temporal trends in the prevalence of diabetes mellitus in a rural community in Sri Lanka. J R Soc Promot Health. 2004 Mar;124(2):92-4. doi: 10.1177/146642400412400214.

  PMID: 15067982 BACKGROUND

• Jourdan C, Petersen AK, Gieger C, Doring A, Illig T, Wang-Sattler R, Meisinger C, Peters A, Adamski J, Prehn C, Suhre K, Altmaier E, Kastenmuller G, Romisch-Margl W, Theis FJ, Krumsiek J, Wichmann HE, Linseisen J. Body fat free mass is associated with the serum metabolite profile in a population-based study. PLoS One. 2012;7(6):e40009. doi: 10.1371/journal.pone.0040009. Epub 2012 Jun 27.

  PMID: 22761945 BACKGROUND

• Katulanda P, Constantine GR, Mahesh JG, Sheriff R, Seneviratne RD, Wijeratne S, Wijesuriya M, McCarthy MI, Adler AI, Matthews DR. Prevalence and projections of diabetes and pre-diabetes in adults in Sri Lanka--Sri Lanka Diabetes, Cardiovascular Study (SLDCS). Diabet Med. 2008 Sep;25(9):1062-9. doi: 10.1111/j.1464-5491.2008.02523.x.

  PMID: 19183311 BACKGROUND

• Katulanda P, Sheriff MH, Matthews DR. The diabetes epidemic in Sri Lanka - a growing problem. Ceylon Med J. 2006 Mar;51(1):26-8. doi: 10.4038/cmj.v51i1.1373.

  PMID: 16898034 BACKGROUND

• Ramachandran A, Ma RC, Snehalatha C. Diabetes in Asia. Lancet. 2010 Jan 30;375(9712):408-18. doi: 10.1016/S0140-6736(09)60937-5. Epub 2009 Oct 28.

  PMID: 19875164 BACKGROUND

• Unger RH, Zhou YT. Lipotoxicity of beta-cells in obesity and in other causes of fatty acid spillover. Diabetes. 2001 Feb;50 Suppl 1:S118-21. doi: 10.2337/diabetes.50.2007.s118.

  PMID: 11272168 BACKGROUND

• Vandenheede H, Deboosere P, Stirbu I, Agyemang CO, Harding S, Juel K, Rafnsson SB, Regidor E, Rey G, Rosato M, Mackenbach JP, Kunst AE. Migrant mortality from diabetes mellitus across Europe: the importance of socio-economic change. Eur J Epidemiol. 2012 Feb;27(2):109-17. doi: 10.1007/s10654-011-9638-6. Epub 2011 Dec 14.

  PMID: 22167294 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood (EDTA plasma, buffy coats and serum) samples are stored in Fluid X biobanking tubes. The tubes are labeled with a unique burnt-in 2D barcode and the respective plain digit number readable with magnifying glasses.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Genetic Predisposition to Disease; Insulin Resistance; Hypertriglyceridemia; Hyperinsulinism

Interventions

Restraint, Physical; Hematologic Tests

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Martin Fiedler, MD, MBA

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: March 28, 2023
• Study Start: July 31, 2014
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)