Diabetes ComplicationsHEIST-DiCNCT03022721
Heidelberg Study on Diabetes and Complications
An observational study of Diabetes Complications, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Complications
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Inclusion Criteria Age between 18 and 75 years Persons with manifest diabetes mellitus type 1 or type 2 and diagnosis according to DDG guidelines 2011, that is HbA1c of 6,5 percent or higher after exclusion of false values, more than 200 mg per dl two hours after glucose in the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice Healthy persons without diabetes or impairment of glucose metabolism in the oGTT according to DDG guidelines 2011 fasting plasma glucose less than 100 mg per dl and 2 hour plasma glucose less than 140 mg per dl Pre diabetics with impaired fasting glucose between 100 mg per dl and 125 mg per dl, or impaired glucose tolerance with 2 hour glucose values between 140 and 199 mg per dl in the oGTT, all values from venous plasma
Exclusion Criteria General exclusion criteria Secondary types of Diabetes, ADA criteria type 3 B H Current pregnancy Acute infections or fever Immune suppressant therapy Severe psychiatric diseases requiring treatment, including personality disorders, schizophrenia, depression Known alcohol or drug dependency Severe heart NYHA stadium IV, kidney, or liver insufficiency Non diabetic liver disease, for example PBC, PSC, Wilsons disease, hemochromatosis, autoimmune hepatitis severe peripheral artery disease stadium IV non diabetic glomerulopathy Cancer or other malignant diseases within the last 5 years Infectious diseases like hepatitis B, C, E, or HIV Other severe autoimmune diseases Current participation in an interventional study Anemia or disorders of bone marrow Exclusion criteria for MRI Pacemaker or ICD Metallic and magnetic implants, for example mechanic cardiac valves replacements, joint prostheses, clips after vascular surgery, middle or inner ear implants, recent tooth implants, penile implants Waist circumference more than 135 cm Claustrophobia Allergies against MRI contrast Impaired kidney function with a GFR less than 65 ml per min
Exclusion criteria for clamp study Past history of deep vein thrombosis or pulmonary embolism Routine laboratory test results less than 80 percent below lower reference value of Ferritin, iron, leucocytes, hemoglobin, hematocrite, RBC, platelets, blood alcohol Level
Exclusion criteria for bioimpedance measurement Pacemaker or ICD
Exclusion criteria for lung function testing Ignoring or non understanding of the instructions Body weight more than 160 kg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine, University of Heidelberg
Heidelberg, 69120
Stefan Kopf, MD, +49-6221- ext. 37790, stefan.kopf@med.uni-heidelberg.de
Jan B Groener, MD, +49-6221- ext. 37639, jan.groener@med.uni-heidelberg.de
About this study
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.
Read the detailed description
The prospective observational study entitled "Heidelberg Study on Diabetes and Complications" is designed to show that diabetes according to the current medical definition does not exist. Without question, there is an autoimmune disease that destroys beta cells in the pancreas, which leads to absolute insulin deficiency with consecutively elevated blood glucose levels. This disease is defined as diabetes mellitus type 1. Insulin treatment is absolutely necessary in this state, since absolute insulin deficiency leads to lipolysis with consecutive ketoacidosis and eventually death. On the other hand, type 2 diabetes is generally defined as relative insulin deficiency with consecutively elevated blood glucose levels. This disease is often mentioned in the context of the metabolic syndrome, which additionally comprises obesity, arterial hypertension, dyslipidemia, and cardiovascular diseases. Therefore, only the name "diabetes mellitus" is shared by these two diseases, which means "sweet flow", therefore only describing a symptom.
Multiple interventional studies were aimed on avoiding or reducing the development of late diabetic complications (nephropathy, neuropathy, retinopathy, microangiopathy). This is true for both type 1 and type 2 diabetes. Up to this day, no study was able to demonstrate that treatment of normalization of blood glucose levels reduces or even reverses development of these complications. Moreover, several type 2 diabetic patients developed typical diabetic complications before definitive manifestation of the actual disease.
Therefore, we hypothesize that late diabetic complications stand in no primary context with blood glucose control, but are associated with other metabolic disorders. One aspect are reactive metabolites (glyoxal, methylglyoxal, 3-DG), which are formed in glycolysis and lipolysis in the context of energy production of cells. These metabolites are detoxified to lactate by certain enzymes. In case this detoxification is compromised, or production of these metabolites elevated, so called advanced glycation endproducts (AGEs) can form. Moreover, within the process of energy production, reactive oxygen species (ROS) and oxydative stress are more pronounced, which can have direct influence on cellular metabolism. This interaction leads to inflammation and DNA damage. Survival of the cells is dependent on defense mechanisms, which seem to be genetically determined, with cellular ageing playing a role as well (cellular senescence). With advanced ageing, cells lose these defense mechanisms against these permanent metabolic attacks.
Therefore, the following hypotheses arise:
- Diabetes mellitus type 2 is no independent disease, but a late complication of metabolic imbalance
- Typical "late diabetic complications" are not based on insufficient blood glucose lowering therapy, but on the basis of this metabolic imbalance, and can therefore affect every patient, even without manifested "diabetes mellitus type 2"
- Diabetes mellitus type 1 is an autoimmundisease with consecutive absolute insulin deficiency, however manifestation of late diabetic complications is based on the same metabolic dysbalance (overlap with type 2).
In order to investigate these hypotheses, study participants will be profoundly examined once yearly concerning glycemic metabolic state and clinical findings related to micro- and macrovascular diabetic complications, Moreover, reactive metabolites like AGEs, ROS, methylglyoxal, and DNA damage as well as other parameters associated with cellular senescence will be examined. We will also collect information concerning quality of life, well-being, depression, and neuropathic pain.
This is the first study of its kind to include non-diabetics, pre-diabetics, and diabetics with the possibility to study differences and common ground regarding cellular metabolism. Moreover, to the best of our knowledge, there is no precise clinical characterization of peripheral nerve function in pre-diabetics, although some of these patients already complain about neuropathic symptoms. In addition to that, the natural clinical course not only in diabetics, but also in pre-diabetics will be observed over a longer period of time. Finally, changes in surrogate markers over the natural course of pre-diabetes can be observed for the first time, onset of type 1 or type 2 diabetes can be registered immediately, and all patients can be directly compared to healthy controls.
- Conditions
- Diabetes Complications
- Being tested
- No interventions are planned for this study.
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions are planned for this study.Other
No interventions are planned for this study, it is purely observational.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No interventions are planned for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Kopf MD, Heidelberg University
- Investigators
- Stefan Kopf, MD, Principal investigator, Head of the Clinical Study Center for Diabetes Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022721
- Sponsor's protocol ID
- S-383/2016
- Acronym
- HEIST-DiC
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No sharing of individual participant data is planned.
Publications
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 May 1;167(5):1146-1156. doi: 10.1097/j.pain.0000000000003898. Epub 2026 Jan 6.
PubMed 41494160Kliemank 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.
PubMed 40797027Schimpfle L, Tsilingiris D, Mooshage CM, Kender Z, Sulaj A, von Rauchhaupt E, Szendroedi J, Herzig S, Goepfert J, Groener J, Nawroth PP, Bendszus M, Heiland S, Kurz FT, Jende JME, Kopf S. Phase Angle of Bioelectrical Impedance Analysis as an Indicator for Diabetic Polyneuropathy in Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2024 Oct 15;109(11):e2110-e2119. doi: 10.1210/clinem/dgad737.
PubMed 38215056Mooshage 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.
PubMed 38191821Mooshage 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.
PubMed 38019287Mooshage 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.
PubMed 37579325Tsilingiris 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.
PubMed 37139855Jende 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.
PubMed 31974140Groener 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.
PubMed 31826867Kopf 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.
PubMed 30389624
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heidelberg Study on Diabetes and Complications
- ClinicalTrials.gov ID
- NCT03022721
- Acronym / sponsor ID
- HEIST-DiC / S-383/2016
- Conditions
- Diabetes Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prospective observational study entitled "Heidelberg Study on Diabetes and Complications" is designed to show that diabetes according to the current medical definition does not exist. Without question, there is an autoimmune disease that destroys beta cells in the pancreas, which leads to absolute insulin deficiency with consecutively elevated blood glucose levels. This disease is defined as diabetes mellitus type 1. Insulin treatment is absolutely necessary in this state, since absolute insulin deficiency leads to lipolysis with consecutive ketoacidosis and eventually death. On the other hand, type 2 diabetes is generally defined as relative insulin deficiency with consecutively elevated blood glucose levels. This disease is often mentioned in the context of the metabolic syndrome, which additionally comprises obesity, arterial hypertension, dyslipidemia, and cardiovascular diseases. Therefore, only the name "diabetes mellitus" is shared by these two diseases, which means "sweet flow", therefore only describing a symptom.
Multiple interventional studies were aimed on avoiding or reducing the development of late diabetic complications (nephropathy, neuropathy, retinopathy, microangiopathy). This is true for both type 1 and type 2 diabetes. Up to this day, no study was able to demonstrate that treatment of normalization of blood glucose levels reduces or even reverses development of these complications. Moreover, several type 2 diabetic patients developed typical diabetic complications before definitive manifestation of the actual disease.
Therefore, we hypothesize that late diabetic complications stand in no primary context with blood glucose control, but are associated with other metabolic disorders. One aspect are reactive metabolites (glyoxal, methylglyoxal, 3-DG), which are formed in glycolysis and lipolysis in the context of energy production of cells. These metabolites are detoxified to lactate by certain enzymes. In case this detoxification is compromised, or production of these metabolites elevated, so called advanced glycation endproducts (AGEs) can form. Moreover, within the process of energy production, reactive oxygen species (ROS) and oxydative stress are more pronounced, which can have direct influence on cellular metabolism. This interaction leads to inflammation and DNA damage. Survival of the cells is dependent on defense mechanisms, which seem to be genetically determined, with cellular ageing playing a role as well (cellular senescence). With advanced ageing, cells lose these defense mechanisms against these permanent metabolic attacks.
Therefore, the following hypotheses arise:
- Diabetes mellitus type 2 is no independent disease, but a late complication of metabolic imbalance
- Typical "late diabetic complications" are not based on insufficient blood glucose lowering therapy, but on the basis of this metabolic imbalance, and can therefore affect every patient, even without manifested "diabetes mellitus type 2"
- Diabetes mellitus type 1 is an autoimmundisease with consecutive absolute insulin deficiency, however manifestation of late diabetic complications is based on the same metabolic dysbalance (overlap with type 2).
In order to investigate these hypotheses, study participants will be profoundly examined once yearly concerning glycemic metabolic state and clinical findings related to micro- and macrovascular diabetic complications, Moreover, reactive metabolites like AGEs, ROS, methylglyoxal, and DNA damage as well as other parameters associated with cellular senescence will be examined. We will also collect information concerning quality of life, well-being, depression, and neuropathic pain.
This is the first study of its kind to include non-diabetics, pre-diabetics, and diabetics with the possibility to study differences and common ground regarding cellular metabolism. Moreover, to the best of our knowledge, there is no precise clinical characterization of peripheral nerve function in pre-diabetics, although some of these patients already complain about neuropathic symptoms. In addition to that, the natural clinical course not only in diabetics, but also in pre-diabetics will be observed over a longer period of time. Finally, changes in surrogate markers over the natural course of pre-diabetes can be observed for the first time, onset of type 1 or type 2 diabetes can be registered immediately, and all patients can be directly compared to healthy controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes | – | Other: No interventions are planned for this study.Patients with both type 1 and type 2 Diabetes will be enrolled, Independent of Diabetes Duration, therapy etc. No interventions are planned. |
| Pre-Diabetics | – | Other: No interventions are planned for this study.Patients who have either imparied fasting Glucose or impaired Glucose tolerance in the oral Glucose tolerance test. No interventions are planned. |
| Healthy controls | – | Other: No interventions are planned for this study.Study participants without Diabetes or Pre-diabetes in the oral Glucose tolerance test. no interventions are planned. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions are planned for this study.No interventions are planned for this study, it is purely observational. | Other | Healthy controls, Patients with diabetes, Pre-Diabetics |
Primary outcome
Development of diabetic complications
Time frame: 10 years
Diabetic complications include diabetic nephropathy, diabetic retinopathy, diabetic polyneuropathy, autonomous neuropathy, or macrovascular complications such as stroke, peripheral artery disease, or myocardial infarction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Derived from this study: PubMed 41494160Eldesouky 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 May 1;167(5):1146-1156. doi: 10.1097/j.pain.0000000000003898. Epub 2026 Jan 6.
- Derived from this study: PubMed 40797027Kliemank 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.
- Derived from this study: PubMed 38215056Schimpfle L, Tsilingiris D, Mooshage CM, Kender Z, Sulaj A, von Rauchhaupt E, Szendroedi J, Herzig S, Goepfert J, Groener J, Nawroth PP, Bendszus M, Heiland S, Kurz FT, Jende JME, Kopf S. Phase Angle of Bioelectrical Impedance Analysis as an Indicator for Diabetic Polyneuropathy in Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2024 Oct 15;109(11):e2110-e2119. doi: 10.1210/clinem/dgad737.
- Derived from this study: PubMed 38191821Mooshage 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.
- Derived from this study: PubMed 38019287Mooshage 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.
- Derived from this study: PubMed 37579325Mooshage 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.
- Derived from this study: PubMed 37139855Tsilingiris 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.
- Derived from this study: PubMed 31974140Jende 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.
- Derived from this study: PubMed 31826867Groener 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.
- Derived from this study: PubMed 30389624Kopf 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.
- Individual participant dataSharing planned: No. No sharing of individual participant data is planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Kopf, MD principal investigator
Head of the Clinical Study Center for Diabetes Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Complications, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Kopf, MD (+49-6221-56 ext. 37790, stefan.kopf@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of diabetic complications (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022721, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.