Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
10 participants
OBSERVATIONAL
2017-07-11
2017-10-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The liver related glucose release into the blood circulation is crucial for the brain function and overall survival during fasting. In addition, a compensatory rise in asprosin is expected during a hypoglycemic episode. In this pilot study, the asprosin concentration is measured both in participants with type 1 Diabetes mellitus, with or without hypoglycemia unawareness during a hypoglycemic phase. These relevant measurements are compared in the two subgroups, consisting of 5 persons each. By correlating asprosin values with other regulating hormones, there is hope to better understand the pathomechanism of hypoglycemia unawareness. Recently discovered is that the recombinant asprosin administration in mice allows both the blood glucose and the insulin to rise. It is therefore very likely that further studying of asprosin could provide new insights into the (patho) physiology of the intermediary metabolism disorder.
According to the above, the following hypotheses arise:
Asprosin dynamics relating to serum Glucose levels under controlled alteration:
Asprosin, as fast induced protein hormone, increases serum levels in type 1 diabetics with or without diabetes late complications during a hypoglycemic phase. Asprosin increases serum levels more significantly in diabetics without hypoglycemia unawareness compared to diabetics with hypoglycemia unawareness. There is probably no correlation between asprosin and the previous known regulating hormones. In order to investigate these hypotheses, study participants will be initially profoundly examined in our Clinical Study Center regarding both their glycemic metabolical responses and the clinical findings relating to their possible micro- and macrovascular complications. In addition to this quality of life, well being, depression and neuropathic pain is going to be taken into account. This is to be the first study of its kind, in which plasma levels of asprosin is determined and Type 1 diabetics with and without hypoglycemia unawareness are thoroughly examined in order to identify possible differences and similarities for the better determination of the new hormone utilizing the framework of hyperinsulinemic Clamp Tests. The intention behind is to better understand the (patho) physiology of the hypoglycaemia unawareness, as well as to better characterize the physiological properties of asprosin
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diabetics without hypoglycemia awareness
Diabetic patients without impaired hypoglycemia awareness. No interventions were performed, the study is purely observational.
Clamp study
Clamp study to achieve high, normal, and lower glucose levels to study the dynamics of Asprosin.
Diabetics with hypoglycemia awareness
Diabetic patients with impaired hypoglycemia awareness. No interventions were performed, the study is purely observational.
Clamp study
Clamp study to achieve high, normal, and lower glucose levels to study the dynamics of Asprosin.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clamp study
Clamp study to achieve high, normal, and lower glucose levels to study the dynamics of Asprosin.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI between 20 und 35 kg per m2
* Persons with manifest diabetes mellitus type 1 and diagnosis according to according to DDG guidelines 2011 oGTT, HbA1c more than 6.5 percent in the absence of adulteration of the HbA1c, over 200 mg per dl in the 2 hour value of the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice.
* Persons who are not aware of hypoglycemia symptoms at glucose levels above 50 mg per dl
* Age between 18 and 75 years
* BMI between 20 und 35 kg per m2
* Persons with manifest diabetes mellitus type 1 and diagnosis according to DDG guidelines 2011 oGTT, HbA1c more than 6.5 percent in the absence of adulteration of the HbA1c, over 200 mg per dl in the 2 hour value of the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice.
Exclusion Criteria
* Acute infections or fever Immune-suppressant therapy
* Severe psychiatric diseases requiring treatment (for example personality disorders, schizophrenia, depression)
* Known alcohol or drug dependency
* Severe heart, kidney, or liver insufficiency NYHA stadium IV
* Non-diabetic liver disease (for example PBC, PSC, Wilson's 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
* Past history of deep vein thrombosis or pulmonary embolism
* Routine laboratory test results less than 80 percent below lower reference value: Ferritin, iron, leucocytes, haemoglobin, hematocrit, RBC, platelets, blood alcohol levels.
* measurement Pacemaker or ICD
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heidelberg University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stefan Kopf MD
Head of the Clinical Study Center for Diabetes Research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stef Kopf, MD
Role: PRINCIPAL_INVESTIGATOR
Head of the Clinical Study Center for Diabetes Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Klinik, University Hospital
Heidelberg, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-550/2016
Identifier Type: -
Identifier Source: org_study_id