Actively Recruiting

Age: 6Years - 18Years
All Genders
NCT05159856

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

Led by Steno Diabetes Center Copenhagen · Updated on 2025-06-03

400

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

Sponsors

S

Steno Diabetes Center Copenhagen

Lead Sponsor

S

Steno Diabetes Center Sjaelland

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 18 years
  • Type 1 diabetes for more than 12 months
  • Followed at the Pediatric Diabetes outpatient clinic at Steno Diabetes Center Copenhagen
  • Able to understand Danish language both spoken and written
  • Written consent from the child's guardian(s)
Not Eligible

You will not qualify if you...

  • Type 1 diabetes for less than 12 months
  • Known cardiovascular disease
  • Currently taking antihypertensive treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Steno Diabetes Center Copenhagen

Herlev, Herlev, Denmark, 2730

Actively Recruiting

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Research Team

J

Julie A Damm, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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