Fibromyalgia in Patient With Impaired Fasting Glucose

Completed

• Conditions: Fibromyalgia
• Interventions: Diagnostic Test: oral glucose tolerance test (OGTT)

• Registration Number: NCT03871946
• Lead Sponsor: Hitit University

Brief Summary

To assess the frequency of fibromyalgia among women with impaired fasting glucose.

Detailed Description

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 \[FIQ \].

Study Timeline

• Study Start: 2015-08-15
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2019-03
• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-10
• Last Update Submitted: 2019-03-10
• Study First Posted: 2019-03-12
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 146

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	oral glucose tolerance test (OGTT)	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	oral glucose tolerance test (OGTT)	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.

Primary Outcome Measures

Name	Time	Method
the frequency of fibromyalgia among women with impaired fasting glucose.	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