Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics. This prospective observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the Gastroenterology Units of the University of Palermo. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake.
Celiac disease (CD) has been reported to increase the risk of osteoporosis, with a resulting augmented risk of fractures. More recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. That previous study also showed a percentage of NCWS patients had weight loss and anemia: whether these depended on the intestinal malabsorption or not remains unclear. As yet no data are available on the presence and prevalence of low bone mass density (BMD) in NCWS patients. The aims of the present study is: 1) to investigate the prevalence of low BMD in NCWS patient and 2) to search for a possible correlation between BMD and other clinical characteristics, in particular the body mass index (BMI), of NCWS patients.
Study Type
OBSERVATIONAL
Enrollment
270
Antonio Carroccio
Sciacca, Agrigento, Italy
Pasquale Mansueto
Palermo, Italy
Change in bone mineral density (BMD)
BMD will be assessed by dual x-ray absorptiometry (DXA), using a QDR Discovery Hologic DXA scanner in the femoral neck and in the lumbar spine. For each scan, BMD and T-scores will be recorded. A T-score between +1 and -1 is considered normal, between -1 and -2.5 indicates osteopenia, -2.5 or lower indicates osteoporosis. The investigators also will calculate the 10-year fracture risks according to the standardized WHO FRAX equation, computed with BMD (T-score) at the femoral neck.
Time frame: At baseline and at 24 months
Conventional lateral spine x-ray as an assessment of suspected osteoporotic vertebral fractures, using Genant's method
A random sample of the patients and controls will undergo conventional lateral spine x-ray for better assessment of suspected osteoporotic vertebral fractures, according to Genant's method (grade 0, no reduction; grade 1, minimal fracture, 20-25% vertebral height decrease; grade 2, moderate fracture, 25-40% vertebral height decrease; and grade 3, severe fracture, greater than 40% vertebral height decrease).
Time frame: At baseline
Change in serum bone alkaline phosphatase
Serum bone alkaline phosphatase values will be detected (refences values of adults males \< or =20 mcg/L; of adults premenopausal females \< or =14 mcg/L; of adults postmenopausal females \< or =22 mcg/L).
Time frame: At baseline and at 24 months
Change in serum 25-hydroxyvitamin D
Serum 25-hydroxyvitamin D values will be detected (refences values 30.0-74.0 ng/mL).
Time frame: At baseline and at 24 months
Change in serum phosphorus levels
Serum phosphorus levels values will be detected (refences values of subjects \> or =18 years: 2.5-4.5 mg/dL).
Time frame: At baseline and at 24 months
Change in serum calcium levels
Serum calcium levels values will be detected (refences values of males age 18-21 years: 9.3-10.3 mg/dL, age 22 years and older: 8.9-10.1 mg/dL; of females age 18 years and older: 8.9-10.1 mg/dL)
Time frame: At baseline and at 24 months
Change in urinary phosphorus levels
Urinary phosphorus levels values will be detected (refences values 0.4-1.3 g per 24-hour urine sample).
Time frame: At baseline and at 24 months
Change in urinary calcium levels
Urinary calcium levels values will be detected (refences values 100-300 mg per 24-hour urine sample).
Time frame: At baseline and at 24 months
Change in dietary intake and lifestyle
All the participants will fill in a health and lifestyle questionnaire, considering menarche and age at menopause (if applicable), medical and drug abuse history, lifestyle habits (including elimination diet, smoking status, alcohol consumption, Italian espresso coffee drinking and physical activity); history of bone fractures will also be recorded. In order to assess daily caloric intake and calcium intake, the subjects will receive a dietary form containing a printed list of the most common foods.
Time frame: At baseline and at 24 months
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