Diabetes Complications Clinical Trial
Official title:
Heidelberg Study on Diabetes and Complications
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.
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:
1. Diabetes mellitus type 2 is no independent disease, but a late complication of
metabolic imbalance
2. 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"
3. 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.
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