Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.

NCT04682457 | Completed

• 1 other identifier: 2003962
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims is to find out if people with type 1 diabetes diagnosed in later life (after age 30) have the same rapid loss of insulin secretion (measured using C-peptide) that occurs in younger adults with type 1 diabetes. The investigators will recruit 135 participants aged over 30 years with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. The investigators will also recruit a comparison group of 61 participants aged 18-30 with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. C-peptide will be measured during mixed meal tolerance tests (MMTT) performed at baseline, 6 months and a year. This study also aims to test a new more practical way of monitoring insulin secretion at home using a finger prick 'blood spot' rather than time consuming tests in a hospital. Finger-prick C-peptide samples will be collected after the MMTT and by the participants at home throughout the year.

Conditions

Diabetes Mellitus, Type 1; Progression

Outcome Measures

Primary Outcomes (2)

• C-peptide value at a year

  12 month (Mixed Meal Tolerance Test) MMTT area under the curve (AUC) C-peptide.

  12 months

• Change in C-peptide over a year

  Rate of change of MMTT AUC C-peptide over 12 months assessed at regular study visits

  12 months

Secondary Outcomes (3)

• C-peptide value at 12 months

  12 months

• Glucose variability & hypoglycemia

  12 months

• Change in dried blood spot C-peptide

  12 months

Study Arms (2)

Late Onset

Participants diagnosed with Type 1 diabetes at over 30 years of age.

18 to 30

Participants diagnosed with Type 1 diabetes between 18 and 30 years of age

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recent clinical diagnosis of type 1 diabetes

You may qualify if:

• Adults with a clinical diagnosis of Type 1 diabetes within the previous 100 days.
• Aged \>30 at the time of Type 1 diabetes diagnosis OR (additional early onset Type 1 diabetes cohort) aged ≥18 and ≤30 at the time of Type 1 diabetes diagnosis.
• Insulin treated at the time of recruitment
• Able and willing to provide informed consent.

You may not qualify if:

• Pregnancy
• Known monogenic diabetes
• Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Devon & Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Related Publications (1)

• Thomas NJ, Lynam AL, Hill AV, Weedon MN, Shields BM, Oram RA, McDonald TJ, Hattersley AT, Jones AG. Type 1 diabetes defined by severe insulin deficiency occurs after 30 years of age and is commonly treated as type 2 diabetes. Diabetologia. 2019 Jul;62(7):1167-1172. doi: 10.1007/s00125-019-4863-8. Epub 2019 Apr 10.

  PMID: 30969375 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, DNA,

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Disease Progression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angus Jones, MBBS MRCP

  NIHR Exeter Clinical Research Facility

  STUDY DIRECTOR

• Nicholas Thomas, MRCP

  NIHR Exeter Clinical Research Facility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 23, 2020
• Study Start: November 1, 2019
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

GB (1)