Fibromyalgia in Patient With Impaired Fasting Glucose

Fibromyalgia Clinical Trial

Official title:

Fibromyalgia in Patient With Impaired Fasting Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871946
• Other study ID #: Hitit University
• Status: Completed
• Start date: August 15, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: March 2019
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 ].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Diagnostic Test:
• oral glucose tolerance test (OGTT)
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hitit University	Eskisehir Osmangazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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