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Trial record 2 of 334 for:    C-peptide | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT01227538
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Danijela Tatovic, University Hospitals Bristol NHS Foundation Trust

Tracking Information
First Submitted Date October 22, 2010
First Posted Date October 25, 2010
Last Update Posted Date January 7, 2016
Study Start Date April 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01227538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 22, 2010)
  • To compare fasting urinary C-peptide to plasma C-peptide response to mixed-meal [ Time Frame: One year ]
  • 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 ]
  • 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 ]
  • To assess whether urinary C-peptide response to mixed-meal is reproducible in non-observed setting. [ Time Frame: One year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Towards Simple and Non-invasive Assessment of Residual Beta-cell Function in Type 1 Diabetes
Official Title Towards Simple and Non-invasive Assessment of Residual Beta-cell Function in Type 1 Diabetes
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with Type 1 diabetes diagnosed in the last 5 years
Condition 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.
Study Groups/Cohorts 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.
Intervention: Other: Mixed meal stimulated urinary C peptide for the assessment of residual beta cell function
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 6, 2016)
17
Original Estimated Enrollment
 (submitted: October 22, 2010)
30
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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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Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01227538
Other Study ID Numbers ME/2010/3452
10/H0505/87 ( Other Identifier: Berkshire REC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Danijela Tatovic, University Hospitals Bristol NHS Foundation Trust
Study Sponsor University Hospitals Bristol NHS Foundation Trust
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospitals Bristol NHS Foundation Trust
Verification Date January 2016