NCT03022721

Brief Summary

The prospective observational study entitled "Heidelberg Study on Diabetes and Complications" is designed to Monitor the presence and development of diabetic complications in type 1 and type 2 diabetic patients, as well as pre-diabetics. Mail Goal is to detect new metabolic mechanisms or new risk factors for the development of diabetic complications in order to identify risk-subgroups. Non-diabetic controls will be enrolled for reference and comparison.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Sep 2016Sep 2028

Study Start

First participant enrolled

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

11 years

First QC Date

January 12, 2017

Last Update Submit

January 12, 2017

Conditions

Diabetes Complications

Outcome Measures

Primary Outcomes (1)

  • Development of diabetic complications

    Diabetic complications include diabetic nephropathy, diabetic retinopathy, diabetic polyneuropathy, autonomous neuropathy, or macrovascular complications such as stroke, peripheral artery disease, or myocardial infarction.

    10 years

Study Arms (3)

Patients with diabetes

Patients with both type 1 and type 2 Diabetes will be enrolled, Independent of Diabetes Duration, therapy etc. No interventions are planned.

Other: No interventions are planned for this study.

Pre-Diabetics

Patients who have either imparied fasting Glucose or impaired Glucose tolerance in the oral Glucose tolerance test. No interventions are planned.

Other: No interventions are planned for this study.

Healthy controls

Study participants without Diabetes or Pre-diabetes in the oral Glucose tolerance test. no interventions are planned.

Other: No interventions are planned for this study.

Interventions

No interventions are planned for this study.OTHER

No interventions are planned for this study, it is purely observational.

Healthy controlsPatients with diabetesPre-Diabetics

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study Population comprises patients with Diabetes, patients with pre-diabetes, and healthy controls. In total, 500 participants shall be enrolled and observed for 10 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Related Publications (9)

  • Eldesouky O, Seebauer L, Rukwied R, Carr R, Roshan M, Gottlieb H, Tsilingiris D, Kopf S, Herzig S, Fleming T, Kessler J, Szendroedi J, Schmelz M, Kender Z. Mismatch between intact electrical excitability and lost heat pain in diabetic neuropathy. Pain. 2026 Jan 6. doi: 10.1097/j.pain.0000000000003898. Online ahead of print.

    PMID: 41494160DERIVED

  • Kliemank E, von Rauchhaupt E, Seebauer L, Roshan M, Ansmann M, Flegka V, Schimpfle L, Tsilingiris D, Bartl H, Fleming T, Kender Z, Jende JME, Mooshage CM, Schwarz D, Bendszus M, Schirmacher P, Herzig S, Nawroth PP, Kopf S, Szendroedi J, Sulaj A. Cohort profile of the Heidelberg study on diabetes and complications HEIST-DiC. Sci Rep. 2025 Aug 12;15(1):29580. doi: 10.1038/s41598-025-15343-8.

    PMID: 40797027DERIVED

  • Mooshage CM, Schimpfle L, Tsilingiris D, Kender Z, Aziz-Safaie T, Hohmann A, Szendroedi J, Nawroth P, Sturm V, Heiland S, Bendszus M, Kopf S, Jende JME, Kurz FT. Magnetization transfer ratio of the sciatic nerve differs between patients in type 1 and type 2 diabetes. Eur Radiol Exp. 2024 Jan 9;8(1):6. doi: 10.1186/s41747-023-00405-1.

    PMID: 38191821DERIVED

  • Mooshage CM, Tsilingiris D, Schimpfle L, Seebauer L, Eldesouky O, Aziz-Safaie T, Hohmann A, Herzig S, Szendroedi J, Nawroth P, Heiland S, Bendszus M, Kurz FT, Kopf S, Jende JME, Kender Z. A diminished sciatic nerve structural integrity is associated with distinct peripheral sensory phenotypes in individuals with type 2 diabetes. Diabetologia. 2024 Feb;67(2):275-289. doi: 10.1007/s00125-023-06050-y. Epub 2023 Nov 29.

    PMID: 38019287DERIVED

  • Mooshage CM, Tsilingiris D, Schimpfle L, Kender Z, Aziz-Safaie T, Hohmann A, Szendroedi J, Nawroth P, Sturm V, Heiland S, Bendszus M, Kopf S, Kurz FT, Jende JME. Insulin Resistance Is Associated With Reduced Capillary Permeability of Thigh Muscles in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e137-e144. doi: 10.1210/clinem/dgad481.

    PMID: 37579325DERIVED

  • Tsilingiris D, Schimpfle L, von Rauchhaupt E, Sulaj A, Seebauer L, Bartl H, Herzig S, Szendroedi J, Kopf S, Kender Z. Dysmetabolism-related Early Sensory Deficits and Their Relationship With Peripheral Neuropathy Development. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e979-e988. doi: 10.1210/clinem/dgad248.

    PMID: 37139855DERIVED

  • Jende JME, Groener JB, Kender Z, Hahn A, Morgenstern J, Heiland S, Nawroth PP, Bendszus M, Kopf S, Kurz FT. Troponin T Parallels Structural Nerve Damage in Type 2 Diabetes: A Cross-sectional Study Using Magnetic Resonance Neurography. Diabetes. 2020 Apr;69(4):713-723. doi: 10.2337/db19-1094. Epub 2020 Jan 23.

    PMID: 31974140DERIVED

  • Groener JB, Jende JME, Kurz FT, Kender Z, Treede RD, Schuh-Hofer S, Nawroth PP, Bendszus M, Kopf S. Understanding Diabetic Neuropathy-From Subclinical Nerve Lesions to Severe Nerve Fiber Deficits: A Cross-Sectional Study in Patients With Type 2 Diabetes and Healthy Control Subjects. Diabetes. 2020 Mar;69(3):436-447. doi: 10.2337/db19-0197. Epub 2019 Dec 11.

    PMID: 31826867DERIVED

  • Kopf S, Groener JB, Kender Z, Fleming T, Bischoff S, Jende J, Schumann C, Ries S, Bendszus M, Schuh-Hofer S, Treede RD, Nawroth PP. Deep phenotyping neuropathy: An underestimated complication in patients with pre-diabetes and type 2 diabetes associated with albuminuria. Diabetes Res Clin Pract. 2018 Dec;146:191-201. doi: 10.1016/j.diabres.2018.10.020. Epub 2018 Oct 31.

    PMID: 30389624DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, PBMC, whole blood, urine. There is a possibility of DNA extraction from PBMC

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System Diseases

Study Officials

  • Stefan Kopf, MD

    Head of the Clinical Study Center for Diabetes Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Kopf, MD

CONTACT

+49-6221-56stefan.kopf@med.uni-heidelberg.de

Jan B Groener, MD

CONTACT

+49-6221-56jan.groener@med.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Clinical Study Center for Diabetes Research

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

September 1, 2016

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

January 16, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

No sharing of individual participant data is planned.

Locations

DE(1)