- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03871946
Fibromyalgia in Patient With Impaired Fasting Glucose
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Objective: To assess the frequency of fibromyalgia among women with impaired fasting glucose.
Materials and Methods: The sample was selected from the patients who applied to the Internal Medicine clinic and whose fasting blood glucose level were ≥100 and <126 mg/dL in their routine examination [Group1 ] and patients whose fasting blood glucose were less than 100 constituted the control group [Group2 ]. Oral glucose tolerance test [OGTT ] has been applied to patients with impaired fasting glucose and whose 2nd hour OGTT levels were under 140 has been included. Patients were evaluated in terms of fibromyalgia according to modified 2010 ACR Fibromiyalgia Criteria. Functional status was assessed by using the Fibromyalgia Impact Questionnaire [FIQ ].
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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"
|
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.
|
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
the frequency of fibromyalgia among women with impaired fasting glucose.
Tidsramme: 16 month
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Hitit University
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