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Type 1 Diabetes, Immunology, Genetics & Endogenous Insulin Production (TIGI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03490773
Recruitment Status : Active, not recruiting
First Posted : April 6, 2018
Last Update Posted : September 16, 2019
Leiden University Medical Center
King's College London
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

Brief Summary:
Type I diabetes(T1D)T occurs when an individual loses the ability to make enough insulin to control their blood sugar levels. They need insulin injections to replace the insulin production that has been lost. Traditionally people with T1D are thought to make none of their own insulin after diagnosis, but we have recently identified that there are some people who have T1D but go one making insulin for many years. We would like to explore this in more depth and understand why some people with T1D go on making insulin and some do not. This will help us understand the causes of T1D and may help work out ways to protect this remaining insulin production, with improved blood sugar control, and reduced long-term complications of diabetes We aim to explore genetic and immunological factors which impact on the ability of an individual diagnosed with Type I diabetes (T1D) to produce their own insulin. We aim to study individuals who have been diagnosed with T1D with variable duration and assess the genetic and immunological profile of those whose are thought to be producing significant amounts of insulin despite a long duration and those who despite a very short duration, lose insulin production very quickly.

Condition or disease
Type 1 Diabetes Mellitus

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Study Type : Observational
Actual Enrollment : 287 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessing Genetic and Immunological Predictors of Endogenous Insulin Production in Type 1 Diabetes
Actual Study Start Date : November 1, 2014
Estimated Primary Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Primary Outcome Measures :
  1. Difference in immune function in Cpeptide negative and positive [ Time Frame: Within 6 months of last participant visit ]
    The frequency or suppressive function of regulatory T-cells and the frequency of auto reactive CD4 and CD8 T cells between C-peptide positive and C-peptide negative groups, (with patients and controls individually matched for age of diagnosis and duration).

Secondary Outcome Measures :
  1. Difference in HLA type in Cpeptide negative and positive groups [ Time Frame: Within 6 months of last participant visit ]
    The frequency of high and low risk HLA types and the frequency of non-HLA gene polymorphisms associated with T1D risk, between C-peptide positive, and C-peptide negative groups.

Biospecimen Retention:   Samples With DNA
Peripheral Blood Mononuclear Cells (PBMCs) DNA Serum Plasma Urine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All potential participants will be identified from either routine clinical care or from existing research cohorts managed by the Peninsula Research Bank as part of the NIHR Exeter Clinical Research Facility (ECRF). Potential participants who appear to meet the entry criteria will be given written information on the project, followed by the opportunity to discuss the project in more detail with a member of the research team. The research team will be responsible for the recruitment process.

Inclusion Criteria:

  • Clinical diagnosis of Type 1 diabetes
  • Insulin treated
  • Known UCPCR status (positive/negative defined by UCPCR cut off of 0.2nmol/mmol)
  • Age 5-65 years inclusive
  • Able and willing to provide informed consent/assent

Exclusion Criteria:

  • Pregnant or lactating (as this may limit blood sampling and affect T cell function)
  • Any infectious illness within the last 2 weeks if it was a febrile illness, or within 2-3 days if it was non-febrile (as this may activate T cells non-specifically)
  • Taking steroids or other immunosuppressive medications (as these may alter T cell function)
  • Received any immunoglobulin treatments or blood products in the last 3 months (as these may alter T cell function)
  • Any other medical condition which, in the opinion of the investigator, would affect the safety of the subject's participation.
  • Recreational drug or alcohol abuse (excluding cannabis use more than 1 week prior to blood sampling) - drug abuse may alter T cell function.
  • Severe complications of diabetes other than background retinopathy, uncomplicated neuropathy or proteinuria with creatinine in normal reference range (as more severe complications may affect T cell function)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03490773

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Leiden University Medical Center
Leiden, Netherlands
United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, Devon, United Kingdom, EX2 5DW
King's College London
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Leiden University Medical Center
King's College London
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Principal Investigator: Andrew Hattersley, Professor University of Exeter

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Responsible Party: Royal Devon and Exeter NHS Foundation Trust Identifier: NCT03490773    
Other Study ID Numbers: CRF142
141756 ( Other Identifier: IRAS )
13/SW/0312 ( Other Identifier: Research Ethics Committee )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs