NCT03871946

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

March 1, 2019

Last Update Submit

March 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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)

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)

Interventions

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.

Experimental groupcontrol group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-65 years female patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 12, 2019

Study Start

August 15, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share