Fibromyalgia in Patient With Impaired Fasting Glucose
1 other identifier
observational
146
0 countries
N/A
Brief Summary
To assess the frequency of fibromyalgia among women with impaired fasting glucose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedFirst Submitted
Initial submission to the registry
March 1, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedMarch 12, 2019
March 1, 2019
1.4 years
March 1, 2019
March 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
the frequency of fibromyalgia among women with impaired fasting glucose.
Moreover, a significantly higher proportion of Group 1 patients (26%, n = 19) than Group 2 patients (11%, n = 8) were diagnosed with FM
16 month
Study Arms (2)
Experimental group
Experimental group subjects with impaired fasting glucose (IFG) (Group 1) underwent an oral glucose tolerance test (OGTT), and patients with levels \> 140 mg/dL at the 2nd hour were excluded because they were diagnosed with "impaired glucose tolerance"
control group
The control group (Group 2) comprised 73 patients whose fasting blood glucose level was \<100 mg/dL and who agreed to participate in the study.
Interventions
Implementation of OGTT: The patient was seated in a quiet room after 10-12 h of overnight fasting, and blood samples were drawn. Thereafter, 75 g glucose solution dissolved in 300 mL of water was administeredwithin 5 min. Two hours after this,another blood sample was drawn. During the test, the patient wasn't allowed to rest and eat, but not smoke.
Eligibility Criteria
18-65 years female patients
You may qualify if:
- the study group subjects: fasting blood glucose level was between 100 and 126 mg/dL;
- the control group subjects: fasting blood glucose level was \< 100 mg/dL.
You may not qualify if:
- Patients with a severe systemic disease (chronic kidney disease, liver disease etc. ),
- psychiatric disease,
- hypothyroidism or hyperthyroidism,
- any connective tissue disease
- patients who used medications that influenced the fibromyalgia symptoms, such as analgesics, antidepressants, and anticonvulsive medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hitit Universitylead
- Eskisehir Osmangazi Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 1, 2019
First Posted
March 12, 2019
Study Start
August 15, 2015
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
March 12, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share