The blood vessel protecting cell response to exercise in people with and without type 1 diabetes

Not Applicable

Completed

• Conditions: Type 1 diabetes; Nutritional, Metabolic, Endocrine; Type 1 diabetes mellitus

• Registration Number: ISRCTN63739203
• Lead Sponsor: ewcastle University

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34267242/ (added 19/07/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35222269/ (added 06/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Study Completion: 2019-09-30
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

T1D:
1. Aged 18-65 years old
2. Diagnosed with T1D
3. Treated with exogenous insulin (pump or injection)
4. Free from diabetes complications

Healthy:
1. Aged 18-65 years old
2. Free from any chronic diseases

Exclusion Criteria

Cardiovascular disease or detection via ECG screening

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of EPCs (CD34+, CD45dim, VEGFR2 and CD34+, CD45dim, CD31+) measured by flow cytometry pre, immediately post and 1-hour post the exercise test between type 1 diabetes and healthy controls

Secondary Outcome Measures

Name	Time	Method
1. Clinical factors at baseline:1.1. Fitness measured using graded exercise VO2peak test1.2. Glycaemic control measured by CGM time in range/in hypoglycaemia/hyperglycaemia and glycaemic variability parameters and HbA1c via commercially available assay test1.3. Residual beta cell function measured by stimulated serum C-peptide MMTT via commercially available assay test2. Number of progenitor cells ( (1) CD34+ (2) CD34+, CD45dim (3) CD34+, CD45bright (4) CD34+, CD31+ (5) CD34+, VEGFR2+ (6) CD34+, CD45bright, CD31+ (7) CD34+, CD45bright, VEGFR2+) measured by flow cytometry pre, immediately post and 1-hour post the exercise test in participants with type 1 diabetes and healthy controls3. Number of EPCs and progenitors expressing chemokine receptors (CXCR4, CXCR7) and the Mean Fluorescence Intensity (MFI) of these chemokine receptors measured using flow cytometry pre, immediately post and 1-hour post the exercise test in type 1 diabetes and healthy control participants