FibromyalgiaNCT03871946
Fibromyalgia in Patient With Impaired Fasting Glucose
An observational study of Fibromyalgia, run by Hitit University.
Trial summary
To assess the frequency of fibromyalgia among women with impaired fasting glucose. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- oral glucose tolerance test (OGTT)
- Type of treatment
- Pill or oral medicine
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2015to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18-65 years female patients
Who may be able to join
- 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.
Who cannot join
- 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
About this study
To assess the frequency of fibromyalgia among women with impaired fasting glucose.
Read the 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
- Being tested
- oral glucose tolerance test (OGTT)
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: Diagnostic Test: oral glucose tolerance test (OGTT) | |
| 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. Receives: Diagnostic Test: oral glucose tolerance test (OGTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start15 Aug 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Responsible party
- Principal investigator, Ayla Cagliyan Turk, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871946
- Sponsor's protocol ID
- Hitit University
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia in Patient With Impaired Fasting Glucose
- ClinicalTrials.gov ID
- NCT03871946
- Acronym / sponsor ID
- Hitit University
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 15 Aug 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ].
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Diagnostic Test: oral glucose tolerance test (OGTT)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" |
| control group | – | Diagnostic Test: oral glucose tolerance test (OGTT)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18-65 years female patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Experimental group, control group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Hitit University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of fibromyalgia among women with impaired fasting glucose. (time frame: 16 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.