Bariatric Surgery Clinical Trial
Official title:
Functional Activity and Safety of a Food for Special Medical Purposes in Subjects Undergoing Bariatric Surgery: a Multicenter Prospective Observational Clinical Trial
NCT number | NCT06152965 |
Other study ID # | GS/01/19 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 26, 2021 |
Est. completion date | February 27, 2023 |
Verified date | November 2023 |
Source | Bioitalia srl |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 27, 2023 |
Est. primary completion date | February 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - age >18yrs - Written Informed consent done - Bariatric surgery done Exclusion Criteria: - alcool or drugs abuse - psychiatric illness - allergy |
Country | Name | City | State |
---|---|---|---|
Italy | Obesity and Lipodystrophy Center, University Hospital of Pisa | Pisa |
Lead Sponsor | Collaborator |
---|---|
Bioitalia srl |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical efficacy of Bariatrifast on vitamins concentration | *25-OH Vitamin D3 in microgram/Liter (mcg/L) and vitamin B12 in nanogram/Liter (ng/L) | 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 | |
Secondary | evaluation of other parameters from blood test | 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 |
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 | |
Secondary | evaluation of body composition | * Body weight (kilograms) | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04517591 -
Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study
|
N/A | |
Active, not recruiting |
NCT04433338 -
The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery
|
N/A | |
Completed |
NCT05854875 -
Diabetes Remission After RYGBP and RYGBP With Fundus Resection
|
N/A | |
Completed |
NCT00535600 -
Effects of Bariatric Surgery on Insulin
|
||
Withdrawn |
NCT04771247 -
Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy
|
N/A | |
Not yet recruiting |
NCT03203161 -
Registry on Obesity Surgery in Adolescents
|
||
Enrolling by invitation |
NCT02552433 -
Complications in Body Contouring Surgery
|
||
Completed |
NCT02525016 -
Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
|
Phase 3 | |
Recruiting |
NCT01984762 -
Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.
|
N/A | |
Not yet recruiting |
NCT01652105 -
Randomized Trial of Preoperative Diets Before Bariatric Surgery
|
N/A | |
Completed |
NCT00989157 -
Effects of Gastric Bypass on Blood Levels of Duloxetine
|
Phase 3 | |
Completed |
NCT03609632 -
Understanding Hypoglycaemia After Bariatric Surgery
|
N/A | |
Completed |
NCT05454696 -
Online Clinic Pilates Exercises in Patients Undergoing Bariatric Surgery
|
N/A | |
Completed |
NCT04040647 -
Tolerance of Early Postoperative Mobilization and Ambulation
|
||
Recruiting |
NCT04297306 -
Virtual Reality Exercise Gaming in Patients Awaiting Bariatric Surgery
|
N/A | |
Recruiting |
NCT05428618 -
Mobile Application for Bariatric Surgery Patients
|
N/A | |
Not yet recruiting |
NCT03975244 -
Semi-supervised Exercise Program Before Bariatric Surgery
|
N/A | |
Not yet recruiting |
NCT03900481 -
Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity
|
N/A | |
Recruiting |
NCT06218953 -
The Impact of Preoperative Anemia on Postoperative Anemia and Related Nutrient Abnormalities After Bariatric Surgery
|
||
Recruiting |
NCT06157606 -
Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy
|