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Fibromyalgia in Patient With Impaired Fasting Glucose

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ClinicalTrials.gov Identifier: NCT03871946
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Eskisehir Osmangazi University
Information provided by (Responsible Party):
Ayla Cagliyan Turk, Hitit University

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

Condition or disease Intervention/treatment
Fibromyalgia 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 ].


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Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fibromyalgia in Patient With Impaired Fasting Glucose
Actual Study Start Date : August 15, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Dextrose

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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
18-65 years female patients
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

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Responsible Party: Ayla Cagliyan Turk, Principal Investigator, Hitit University
ClinicalTrials.gov Identifier: NCT03871946     History of Changes
Other Study ID Numbers: Hitit University
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases