This study aims to analyze whether cyclic glycine proline is involved in the self-healing process during the early stages of metabolic dysfunction in people with type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN76855091
• Lead Sponsor: The cGP LAB, New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-01
• Study Start: 2024-07-31
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Male and female participants, 45 to 80 years of age
2. Medical history and clinical diagnosis of T2DM either without or with medical history and clinical diagnosis of dyslipidaemia, hypertension and/or clinical diagnosis of foot DP

Exclusion Criteria

1. Type 1 diabetes
2. Pregnancy related T2DM and/or hypertension
3. Poorly controlled glucose metabolism (fasting glucose >15 mmol/L)
4. T2DM with severe complications such as diabetes ketoacidosis, stage 4 diabetic nephropathy and diabetic foot ulcer
5. Other causes of hypertension and chronic kidney diseases
6. Drug, injury or neurological condition induced peripheral neuropathy
7. Medical history of degenerative conditions
8. Cognitive impairment and major mental health issues
9. Severe depression and anxiety

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
During a single hospital visit, the fasting blood samples and spot urine samples are taken for biological analysis. As a primary outcome, glucose metabolism is evaluated by measuring fasting glucose concentration, HBA1c (%), triglyceride/glucose index.

Secondary Outcome Measures

Name	Time	Method
Measured at a single time point:<br>1. Blood pressure is evaluated by measuring systolic and diastolic blood pressure<br>2. Foot diabetic peripheral neuropathy is evaluated by measuring foot sensation using Semmes-Weinstein monofilament test, vibration and warm/cold perceptions tests<br>3. Kidney function is evaluated by measuring urine concentration of albumin, albumin/creatinine ratio, plasma urea nitrogen and its ratio with plasma creatinine