Fibromyalgia in Patient With Impaired Fasting Glucose

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Diagnostic test: oral glucose tolerance test (OGTT)

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 Type: Observational
• Enrollment (Actual): 146

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

18-65 years female patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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"	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hitit University
• Collaborators: Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 10, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 10, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Hitit University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No