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OpenTrials
Completed

NCT Number: NCT03871946

Fibromyalgia in Patient With Impaired Fasting Glucose

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

About this study

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 ].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral glucose tolerance test (oGTT)

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.

Primary outcomes

  1. the frequency of fibromyalgia among women with impaired fasting glucose.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Collaborators

  • Eskisehir Osmangazi University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2019
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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