A cross-sectional pilot study examining the role of circulating immune cells in the presence of type 1 and type 2 diabetes

• Conditions: Type-1 diabetes; Type-2 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618001846213
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-14
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Sex: All

Age: 18 - 65 yrs

Inclusion criteria;
Non-diabetic: any healthy, non-diabetic (normoglycemic) individual
Diabetic: Any patients with clinically diagnosed type-1 or type-2 diabetes

Informed consent: participant must be able to give personal informed consent
Participation in the study: participant must be able to co-operate sufficiently to allow the proposed study to progress.

Concomitant medications: no restriction is made in the use of concomitant medications, which will be left to the treating specialist

Exclusion Criteria

known

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with increased leukocyte abundance<br>(Flow cytometric analysis)[Day of collection (immediate)]

Secondary Outcome Measures

Name	Time	Method
The presence of intraleukocyte O-GlcNAcylation as assessed by (composite secondary outcome);<br>(i) Western blot. Relevant protein abundance using specific monoclonal antibodies (anti-RL2, anti-OGT and anti-OGA) will be utilised to highlight the presence of any O-GlcNAcylation.<br>(ii) Gene expression assessed by quantitative PCR (Genes of interest: OGT, OGA, GFAT1, GFAT [1-3 months post blood collection];Plasma cytokine levels as assessed by cytokine ELISA assay(s). This is an exploratory outcome and will be determined after flow cytometric analysis,<br>[1-3 months post collection]