Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes

NCT05159856 | Recruiting DMC

• 1 other identifier: H-20038547
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: To investigate early markers of long-term diabetic complications and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D). Background: Most Danish children and adolescents with T1D do not achieve their metabolic target and are at increased risk of developing long-term diabetic complications, reducing their life expectancy and increase their morbidity rate. Hence, improved metabolic control, a better understanding of what optimal metabolic control means, combined with detailed monitoring of the first markers of long-term complications and their reversibility or lack thereof are needed. Methods: A prospectivel study of 400 children, aged 6-18 years old, with T1D\>12 months. Early markers of long-term diabetic complications will be investigated as arterial stiffness, nerve dysfunction and nephropathy. Data on T1D onset, duration, treatment modality, self-monitoring-blood-glucose profiles, growth, weight, and pubertal status will be collected. Blood sampling will include routine tests and markers of glucose, lipid, bone, and gastrointestinal metabolism. DXA-scan, Fibroscan, bone-age, eye-examination and physical activity will be measured. Data on retrospective glucose- and lipid-profiles will be collected. The children will be offered a followup every 5 years for the next two decades. Perspectives: This study provides novel insight into the frequency of early markers of long-term diabetic complications and its association to the interplay of the pancreas, adipose, gastrointestinal and bone metabolic axis. Which can assist in identifying subgroups of children and adolescents requiring earlier in-depth screening for early markers of long-term diabetic complications, for putative interventions for prevention, hence reducing morbidity and mortality in T1D.

Conditions

Diabetes Complications; type1diabetes; Children, Only; Diabetic Neuropathies; Arterial Stiffness

Keywords

pediatric; arteriel stiffness; pulse wave velosity; neuropathy; type 1 diabetes; early diabetic complications

Outcome Measures

Primary Outcomes (4)

• Arterial stiffness in children and adolescent with type 1 diabetes (T1D) > 12 months and its association to glycemic control (current and past).

  PWV is a measure of arterial stiffness (m/s) which can be done non invasively at bedside using a device called SphygmoCor CVMS machine (Atcor Medical, Sydney, Australia).

  15.01.2022-15.02.2024

• Peripheral neuropathy assed by DPN-check in children and adolescent with type 1 diabetes (T1D) > 12 months

  Neuropathy assesed by DPN-check: Sural Nerve conduction velocity(m/s) of the Sural nerves by DPN-check.

  15.01.2022-15.02.2024

• Autonom neuropathy assed by Sudoscan in children and adolescent with type 1 diabetes (T1D) > 12 months

  Neuropathy assesed by Sudoscan: Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in feet

  15.01.2022-15.02.2024

• Prevalence of cardivascular autonomic neuropathy assed by VagusDevice in children and adolescent with type 1 diabetes (T1D) > 12 months

  The examination consists of 4 measures, all aimed at measuring heart rate. Measurements are taken for 5 minutes rest, change of position from lying to standing position, during deep breathing and by Valsalva (by breathing in a mouthpiece with a 40 mmHg resistance).

  15.01.2022-15.02.2024

Secondary Outcomes (2)

• The association between early markers of diabetic complications and glycemic control

  15.01.2022-15.02.2024

• The association between early markers of diabetic complications and glycemic control

  15.01.2022-15.02.2024

Study Arms (1)

Prospective cohort study (observational)

400 children/adolescents, aged 6-18 years, with type 1 diabetes for more than 12 months

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

400 children or adolescents with type 1 diabetes for more than 12 months. Age between 6-18 years old.

You may qualify if:

• T1D\>12 months
• Followed at the Pediatric Diabetes outpatient clinic at Steno Diabetes Center Copenhagen
• Speaks and reads Danish well enough to understanding the given oral and written information.
• There is a written consent from the guardianship holder/holders for the child.

You may not qualify if:

• T1D \< 12 months
• Known cardiovascular disease
• Antihypertensive treatment

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Steno Diabetes Center Sjaelland: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, Herlev, 2730, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

routine tests (hemoglobin and iron metabolites, BS, HbA1c, electrolytes, creatinine, urea, LDL, HDL, triglycerid, total cholesterol), and markers of glucose- (insulin, c-peptide), lipid- (leptin, adiponectin) bone- (VitD, calcium, PTH, phosphate, magnesium, BASP, OCN, P1NP, CTX, uOCN, sclerostine, RANKL., Osteoprotegrin and osteoglycin), gastrointestinal (GLP-1, GIP and glucagon). IGF-1 IGF-BP3, thyroid metabolism (TSH, T3, free T4), sex hormones, adrenal androgens, aldosterone and metabolomics. DNa for snp (single nucleotide polymorphisms) and HLA analyses.

MeSH Terms

Conditions

Diabetes Complications; Diabetic Neuropathies; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• jesper johannesen

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie A Damm, MD

CONTACT

+4527287020; julie.agner.damm.02@regionh.dk

Study Design

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

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 16, 2021
• Study Start: May 3, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)