Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 10:41 AM
Study NCT ID:
NCT03530566
Status:
UNKNOWN
Last Update Posted:
2018-05-24
First Post:
2018-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Effectiveness of a Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery
Sponsor:
Protein Supplies SL
Organization:
Study Overview
Official Title:
Prospective Comparative Clinical Study to Evaluate Effectiveness of a Standardized Multidisciplinary Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective multicenter observational clinical study on a dietary regimen in obese patients scheduled for bariatric surgery.
Detailed Description:
Study population: 25 patients with morbid obesity (BMI ≥ 40 kg / m2) or severe obesity (BMI 35 to 39.9 kg / m2) , with two or more comorbidities, scheduled for bariatric surgery within 3 months, and who will start treatment with the multidisciplinary weight loss program (PnK Method) based on diet, exercise and psychological support.
Patients will be followed-up for 3 months, with the following controls: pre-selection, baseline, month 1, month 2, month 3, and control when hospital discharge.
The treatment schedule in these patients will be as follows: a very low calorie ketogenic diet for at least 1 month or until losing 10% of the weight, and then, a low calorie diet with gradual reintroduction of natural foods for 2 months, until surgery.
The investigators will obtain retrospective data from 25 patients treated with the standard diet who met the same inclusion/exclusion criteria as the patients in this study and who similarly resemble in age, sex and BMI, for comparative analysis (control group).
Patients will be followed-up for 3 months, with the following controls: pre-selection, baseline, month 1, month 2, month 3, and control when hospital discharge.
The treatment schedule in these patients will be as follows: a very low calorie ketogenic diet for at least 1 month or until losing 10% of the weight, and then, a low calorie diet with gradual reintroduction of natural foods for 2 months, until surgery.
The investigators will obtain retrospective data from 25 patients treated with the standard diet who met the same inclusion/exclusion criteria as the patients in this study and who similarly resemble in age, sex and BMI, for comparative analysis (control group).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: