Fibromyalgia in Patient With Impaired Fasting Glucose

NCT ID: NCT03871946

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-15
• Study Completion Date: 2016-12-31

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 ].

Conditions

Fibromyalgia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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"

oral glucose tolerance test (OGTT)

Intervention Type: DIAGNOSTIC_TEST

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.

oral glucose tolerance test (OGTT)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: collaborator

Hitit University

OTHER

Sponsor Role: lead

Responsible Party

Ayla Cagliyan Turk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Hitit University

Identifier Type: -

Identifier Source: org_study_id