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Trial registered on ANZCTR
Registration number
ACTRN12613000341729
Ethics application status
Approved
Date submitted
6/03/2013
Date registered
27/03/2013
Date last updated
27/03/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
An observational study on the association of migraines and tension type headaches in patients diagnosed with metabolic syndrome
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Scientific title
An observational study on the association of migraines and tension type headaches in patients diagnosed with metabolic syndrome
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Secondary ID [1]
282078
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Nil
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Universal Trial Number (UTN)
U1111-1140-1780
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
headache
288571
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metabolic syndrome
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Condition category
Condition code
Neurological
288905
288905
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0
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Other neurological disorders
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Metabolic and Endocrine
288906
288906
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0
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Metabolic disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Presence of tension type headache, and migraine were investigated in 120 patients diagnosed as metabolic syndrome.The diagnoses of tension type headache, and migraine defined based on International Classification of Headache Disorders-II criteria. All patients were checked for their serum fasting glucose, total cholesterol, HDL and LDL cholesterol, and triglyceride levels. The patients’ blood pressures and waist circumferences were measured. The age of onset, frequency, severity, unilateral or bilateral localization, presence of aura, associated symptoms, and response to analgesic use were interrogated. Severity of headache was evaluated to be least severe 1 to most severe 10 according to visual analogue scale (VAS). Distribution of metabolic syndrome criteria between groups with and without pain demonstrated that frequency of hypertriglyceridemia was significantly higher in migraine with aura cases when compared with patients diagnosed as episodic tension type headache, and those without pain. A statistically significant negative correlation was observed between response to analgesics, and HDL cholesterol levels in the episodic tension type headache group. In the migraine group a statistically significant negative correlation was found between HDL cholesterol concentrations, and duration of pain in years.Duration of headache prolonged with gradually decreasing levels of HDL cholesterol. A statistically significant positive correlation was found between levels of diastolic pressure, and analgesic requirements of episodic tension type headache group.
Observation time for this trial was seven months.
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Intervention code [1]
286678
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Not applicable
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Comparator / control treatment
No treatment
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The patients who were diagnosed as metabolic syndrome by internist according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP-III) criteria was investigated.
The primary outcome was observation of headache and subtypes in patients with metabolic syndrome.
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Assessment method [1]
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Timepoint [1]
289033
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At baseline
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Secondary outcome [1]
301611
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The observation of migraine and tension type headache in patients with metabolic syndrome.
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Assessment method [1]
301611
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Timepoint [1]
301611
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At baseline
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Eligibility
Key inclusion criteria
Presence of tension type headache, and migraine were investigated in patients diagnosed as metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP-III) criteria.
The diagnoses of tension type headache, and migraine defined based on International Classification of Headache Disorders-II criteria.
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Minimum age
29
Years
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Maximum age
84
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with concomitant serious diseases (cirrhosis, congestive heart failure, malignancies, chronic diseases etc.) and cases diagnosed as secondary headache were excluded from the study.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2011
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Actual
1/11/2011
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Date of last participant enrolment
Anticipated
31/05/2012
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Actual
31/05/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4899
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Turkey
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State/province [1]
4899
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Funding & Sponsors
Funding source category [1]
286855
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Hospital
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Name [1]
286855
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FSM Teaching and Research Hospital
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Address [1]
286855
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Icerenkoy, Atasehir, 34752, Istanbul
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Country [1]
286855
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Turkey
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Primary sponsor type
Hospital
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Name
FSM Teaching and Research Hospital
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Address
Icerenkoy, Atasehir, 34752, Istanbul
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Country
Turkey
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Secondary sponsor category [1]
285644
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None
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Name [1]
285644
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None
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Address [1]
285644
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None
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Country [1]
285644
0
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Other collaborator category [1]
277316
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None
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Name [1]
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None
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Address [1]
277316
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None
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Country [1]
277316
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Background: Our aim was to investigate the association between migraine, tension type headache, and metabolic syndrome.
Methods: Presence of tension type headache, and migraine were investigated in 120 patients diagnosed as metabolic syndrome. All patients were checked for serum fasting glucose, HDL and LDL cholesterol, and triglyceride values. The beginning age, frequency, severity, localization, presence of aura, concomitant symptoms, characteristics of the headache and its responses to the analgesics were interrogated. The severity of the headache was recorded according to the visual analog scale.
Results: Mean age of the patients (female, n= 89; 74.8 %; male, n= 31; 25.8 %) was 54.41 plus/minus 11.60 years (range, 29-84 yrs). Diagnoses of tension type headache and migraine without aura were made for 39 (32.5 %), and 18 (15 %) patients respectively. Mean age of migraine patients was significantly lower relative to the patients with tension type headache and no headache. Incidence of hypertriglyceridemia was significantly higher in migraine patients when compared with cases tension type headache, and without headache. In the tension type headache group, requirement for analgesics decreased as HDL cholesterol levels increased, while need for analgesic drugs increased in line with higher diastolic blood pressures. In the migraine group duration of headache was found as prolonged with decreasing HDL cholesterol levels.
Conclusion: In patients presenting with headache, its association with metabolic syndrome should be considered, and the patients should be especially observed with respect to response to analgesic, and the presence of hypertension, and hyperlipidemia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
38330
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A/Prof Eren Gozke
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Address
38330
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Sedef sk. Onur Sit. 3/17 Barbaros mah. Uskudar, 34662, Istanbul
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Country
38330
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Turkey
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Phone
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0905326165452
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Fax
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Email
38330
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[email protected]
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Contact person for public queries
Name
38331
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A/Prof Eren Gozke
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Address
38331
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Sedef sk. Onur Sit. 3/17 Barbaros mah. Uskudar, 34662, Istanbul
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Country
38331
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Turkey
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Phone
38331
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+905326165452
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Fax
38331
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Email
38331
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[email protected]
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Contact person for scientific queries
Name
38332
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A/Prof Eren Gozke
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Address
38332
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Sedef sk. Onur Sit. 3/17 Barbaros mah. Uskudar, 34662, Istanbul
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Country
38332
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Turkey
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Phone
38332
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+905326165452
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Fax
38332
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Email
38332
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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