Towards Simple and Non-invasive Assessment of Residual Beta-cell Function in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Towards Simple and Non-invasive Assessment of Residual Beta-cell Function in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227538
• Other study ID #: ME/2010/3452
• Secondary ID: 10/H0505/87
• Status: Completed
• Phase: N/A
• First received: October 22, 2010
• Last updated: January 6, 2016
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2016
• Source: University Hospitals Bristol NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: National Health Service, UK:
• Study type: Observational

Clinical Trial Summary

Type 1 diabetes is condition in which progressive autoimmune destruction of insulin-producing beta-cells leads to absolute insulin deficiency. At the time of clinical presentation, it is estimated that 50-80% of beta-cell function has been lost. Good glycaemic control from diagnosis has been shown to preserve beta-cell function. The recent identification of immuno-interventions able to reduce autoimmune destruction and preserve beta-cell function has lead to an increased urgency to develop such tools.

With mixed-meal stimulated serum C-peptide being a gold standard, there are currently no tests that are suited for use in clinical practice to detect and monitor residual beta cell function. There is a therefore a need for a test that is sufficiently sensitive to assess beta cell function reserve in Type 1 diabetes for clinical practice purposes, which will be simple, reproducible and suitable for use even in the non-observed setting.

Using mixed meal stimulation of plasma C-peptide (stable by-product in insulin secretion that reliably reflects insulin production) response as a reference, we propose to compare mixed meal stimulated urinary C-peptide as potential candidate for this application. This is a pilot investigation in which a sample of 30 participants will be recruited.

It is anticipated that the current project will identify a simple method for analysing beta cell reserve in Type 1 diabetes. This will then be applied to screening clinic populations of recently diagnosed patients with type 1 diabetes. The aim will be to identify subjects who may be suitable for early intensified insulin regimes (e.g. insulin pump therapy) and novel immuno-intervention strategies designed to preserve residual beta cell function and improve long-term outcomes. Currently such immunointervention has been reserved for subjects within 3 months of diagnosis only, excluding a significant number of subjects who may potentially benefit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:1. 1. Type 1 diabetes diagnosed in the last 5 years 2. Age 18-45 years

3. BMI between 18.5 and 29.9 4. Insulin requirement less than 0.8 units/kg

Exclusion Criteria:

1. HbA1c higher than 10% 2. Ongoing steroid treatment or chemotherapy 3. Pregnancy and breast feeding 4. eGFR less than 50ml/min/1.73m2

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Mixed meal stimulated urinary C peptide for the assessment of residual beta cell function
Study will be designed to assess stimulated urinary C-peptide in comparison to mixed-meal stimulated plasma C-peptide response in the same individual in 30 number of patients with Type 1 diabetes.

Locations

Country	Name	City	State
United Kingdom	Joint Clinical Research Unit, UHBristol NHS Foundation Trust	Bristol	Avon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Bristol NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of whether two-hour urinary C-peptide response to mixed-meal (measured as area under the curve on the graph) can be used assess residual beta-cell function in the first 5 years after diagnosis of Type 1 diabetes.		One year	No
Secondary	To compare fasting urinary C-peptide to plasma C-peptide response to mixed-meal		One year	No
Secondary	To compare urinary C-peptide response to mixed meal in each hour post stimulation to plasma C-peptide response to mixed-meal		One year	No
Secondary	To compare total four-hour urinary C-peptide (area under the curve) response to mixed meal to plasma C-peptide response to mixed-meal		One year	No
Secondary	To assess whether urinary C-peptide response to mixed-meal is reproducible in non-observed setting.		One year	No