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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University Hospitals Bristol NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT01227538
First received: October 22, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Other: Mixed meal stimulated urinary C peptide for the assessment of residual beta cell function

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Towards Simple and Non-invasive Assessment of Residual Beta-cell Function in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University Hospitals Bristol NHS Trust:

Primary Outcome Measures:
  • 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. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare fasting urinary C-peptide to plasma C-peptide response to mixed-meal [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To compare urinary C-peptide response to mixed meal in each hour post stimulation to plasma C-peptide response to mixed-meal [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To compare total four-hour urinary C-peptide (area under the curve) response to mixed meal to plasma C-peptide response to mixed-meal [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To assess whether urinary C-peptide response to mixed-meal is reproducible in non-observed setting. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227538

Contacts
Contact: Danijela Tatovic, Medical Doctor +44())7833323677 d_tatovic@yahoo.co.uk
Contact: Colin Dayan, Professor in Diabetes

Locations
United Kingdom
Joint Clinical Research Unit, UHBristol NHS Foundation Trust Not yet recruiting
Bristol, Avon, United Kingdom, BS1 8HW
Contact: Danijela Tatovic, Medical Doctor    +44(0)7833323677    d_tatovic@yahoo.co.uk   
Principal Investigator: Danijela Tatovic, Medical Doctor         
Sponsors and Collaborators
University Hospitals Bristol NHS Trust
  More Information

No publications provided

Responsible Party: Dr Danijela Tatovic, UH Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01227538     History of Changes
Other Study ID Numbers: ME/2010/3452, 10/H0505/87
Study First Received: October 22, 2010
Last Updated: October 22, 2010
Health Authority: National Health Service, UK:

Keywords provided by University Hospitals Bristol NHS Trust:
Beta cell reserve, urinary C peptide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014