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NCT Number: NCT01227538

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Joint Clinical Research Unit, UHBristol NHS Foundation Trust

Bristol, Avon, BS1 8HW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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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Treatment and study plan

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.

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.

    Time frame: One year

Secondary outcomes

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

    Time frame: One year

  2. 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

  3. 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

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

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 25, 2010
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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