Bariatric Surgery
Conditions
Keywords
VSG, RYGB, micronutrients deficiency
Brief summary
Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may result in micronutrient and vitamin deficiencies. This monocentric prospective observational study aimed at evaluating the efficacy of a specifically designed vitamin/mineral formula (Bariatrifast) for preventing and treating micronutrient deficiencies in patients submitted to BS.
Detailed description
Although BS effectively reduces body weight, improves metabolic alterations, and enhances overall health, it may also lead to micronutrients deficiency. This prospective observational study aimed at evaluating the effectiveness and safety of a specific FSMP (Food For Special Medical Purposes) in maintaining an adequate vitamin and micronutrient intake in patients with obesity submitted to VSG (Vertical Sleeve Gastrectomy) or RYGB (Roux-en-Y gastric bypass) . The included 20 consecutive patients with severe obesity who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity, followed for one year after surgery.
Interventions
None listed
Sponsors
Bioitalia srl
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* age \>18yrs * Written Informed consent done * Bariatric surgery done
Exclusion criteria
* alcool or drugs abuse * psychiatric illness * allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy of Bariatrifast on vitamins concentration | One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS | \*25-OH Vitamin D3 in microgram/Liter (mcg/L) and vitamin B12 in nanogram/Liter (ng/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of other parameters from blood test | One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS | * Blood counts: red blood cells in number per microliter (10\^6/microliter); hemoglobin in gram/liter (g/L); white blood cells in number per microliter (10\^3/microliter); platelets in number per microliter (10\^3/microliter) * ferritin in microgram/Liter (mcg/L), * ionized calcium in millimoles per liter (mmol/L), * PTH parathormone in nanogram/Liter (ng/L), * folic acid microgram/Liter (mcg/L), recorded at each visit |
| evaluation of body composition | One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS | \* Body weight (kilograms) |
Countries
Italy
Outcome results
None listed