The study objective is the assessment of influence on glucose homeostasis as a consequence of starting switching, discontinuing or doses changes with antidepressants in a population of diabetic patients.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is starting, swithing or discontinuing a
antidepressant or having a dose change with an antidepressant.
The primary outcome is defined as changes in insulin and/or oral antidiabetic
use in the period of 182 days after intervention compared to the period of 30
days prior to intervention.
Secondary outcome
Secundary study outcomes are changes in glucose glucose, HbA1, LDL, HDL and
triglycerides measured during the first diabetes laboratory investigation after
index date compared with the diabetes laboratory investigation prior to index
date.
Background summary
Diabetes Mellitus is a serious chronic disease characterized by hyperglycemia.
Long-term microvascular and macrovascular complications significantly
contribute to morbidity and mortality in patients with Diabetes Mellitus.
Studies revealed that accurate glucose control over time prevents or delays
microvascular complications in both type 1 and type 2 Diabetes Mellitus.
Intensive treatment with insulin and/or oral antidiabetic drugs (OADs),
however, significantly increases the risk of hypoglycemia which is the limiting
factor in glycemic management of diabetes. Major depression has been shown to
be a common morbidity in Diabetes Mellitus. Studies have shown that the risk of
depression is twice as high among adults with chronic Diabetes Mellitus than
among the general population. In addition, among people with Diabetes Mellitus,
those with more complications are most likely to be depressed. Depressive
symptom severity in diabetic patients is a risk factor for poor glycaemic
control.
Comorbid depression in Diabetes Mellitus is frequently treated with
antidepressive agents which could further complicate glycaemic control. The
mechanism behind antidepressant induced disturbances on glucose homeostasis has
not been elucidated yet.
Study objective
The study objective is the assessment of influence on glucose homeostasis as a
consequence of starting switching, discontinuing or doses changes with
antidepressants in a population of diabetic patients.
Study design
Within a population of diabetic patients who are consulting the diabetes nurse
in the hospital patients are screened who are starting, swithing or
discontinuing a antidepressant or having a dose change with an antidepressant.
For each intervention patient one control patient is selected. The outcome is
defined as changes in insulin and/or oral antidiabetic use in the period of 182
days after intervention compared to the period of 30 days prior to
intervention.
Study burden and risks
The extend of the burden and risks associated with participation consists of
filling in a questionnaire. This will take 20 minutes of the patients time.
Besides, an extra sample of blood will be collected from the patient for future
DNA-research. This sample will be taken during a regular sample collection
diabetes laboratory investigation .
Postbus 5500
6130 MB
Nederland
Postbus 5500
6130 MB
Nederland
Listed location countries
Age
Inclusion criteria
Diabetes Mellitus
Starting, discontinuing , switching or dose change with antidepressant
Exclusion criteria
<18 jaar
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14904.096.06 |