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

NCT01227538 | Completed

• 2 other identifiers: ME/2010/345210/H0505/87
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Beta cell reserve, urinary C peptide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• To compare fasting urinary C-peptide to plasma C-peptide response to mixed-meal

  One year

• To compare urinary C-peptide response to mixed meal in each hour post stimulation to plasma C-peptide response to mixed-meal

  One year

• 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

• To assess whether urinary C-peptide response to mixed-meal is reproducible in non-observed setting.

  One year

Study Arms (1)

Stimulated urinary C peptide

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.

Other: Mixed meal stimulated urinary C peptide for the assessment of residual beta cell function

Interventions

Mixed meal stimulated urinary C peptide for the assessment of residual beta cell function OTHER

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.

Stimulated urinary C peptide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with Type 1 diabetes diagnosed in the last 5 years

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead

Study Sites (1)

Joint Clinical Research Unit, UHBristol NHS Foundation Trust

Bristol, Avon, BS1 8HW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Diabetes and Endocrinology

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

GB (1)