Trial Review

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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
Scientific title
An observational study on the association of migraines and tension type headaches in patients diagnosed with metabolic syndrome
Secondary ID [1] 282078 0
Nil
Universal Trial Number (UTN)
U1111-1140-1780
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
headache 288571 0
metabolic syndrome 288572 0
Condition category
Condition code
Neurological 288905 288905 0 0
Other neurological disorders
Metabolic and Endocrine 288906 288906 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 286678 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289033 0
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.
Timepoint [1] 289033 0
At baseline
Secondary outcome [1] 301611 0
The observation of migraine and tension type headache in patients with metabolic syndrome.
Timepoint [1] 301611 0
At baseline

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.
Minimum age
29 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2011
Actual
1/11/2011
Date of last participant enrolment
Anticipated
31/05/2012
Actual
31/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4899 0
Turkey
State/province [1] 4899 0

Funding & Sponsors
Funding source category [1] 286855 0
Hospital
Name [1] 286855 0
FSM Teaching and Research Hospital
Country [1] 286855 0
Turkey
Primary sponsor type
Hospital
Name
FSM Teaching and Research Hospital
Address
Icerenkoy, Atasehir, 34752, Istanbul
Country
Turkey
Secondary sponsor category [1] 285644 0
None
Name [1] 285644 0
None
Address [1] 285644 0
None
Country [1] 285644 0
Other collaborator category [1] 277316 0
None
Name [1] 277316 0
None
Address [1] 277316 0
None
Country [1] 277316 0

Ethics approval
Ethics application status
Approved

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38330 0
A/Prof Eren Gozke
Address 38330 0
Sedef sk. Onur Sit. 3/17 Barbaros mah. Uskudar, 34662, Istanbul
Country 38330 0
Turkey
Phone 38330 0
0905326165452
Fax 38330 0
Email 38330 0
[email protected]
Contact person for public queries
Name 38331 0
Eren Gozke
Address 38331 0
Sedef sk. Onur Sit. 3/17 Barbaros mah. Uskudar, 34662, Istanbul
Country 38331 0
Turkey
Phone 38331 0
+905326165452
Fax 38331 0
Email 38331 0
[email protected]
Contact person for scientific queries
Name 38332 0
Eren Gozke
Address 38332 0
Sedef sk. Onur Sit. 3/17 Barbaros mah. Uskudar, 34662, Istanbul
Country 38332 0
Turkey
Phone 38332 0
+905326165452
Fax 38332 0
Email 38332 0
[email protected]

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