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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04771377
Other study ID # HCB/2020/0028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 10, 2020
Est. completion date June 30, 2023

Study information

Verified date February 2023
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is considered a chronic disease that increases the risk of developing diseases that reduce life expectancy. The treatment of obesity is complex. However, treatments based exclusively on dietary changes have not shown long-term efficacy especially in people with severe obesity. In contrast, in this group of people bariatric surgery (BS) has shown good long-term results in weight loss and maintenance. These changes are accompanied by significant improvements in health, improved quality of life, and reduced mortality. However, the changes in the digestive system created by BS and the high level of dietary restriction, affect the nutritional status and require a proper supplementation of vitamins and minerals during the follow-up. Intense weight loss during the first few months, coupled with an insufficient amount of protein in the diet, can lead to a loss of muscle mass. Excessive muscle loss during the short-term period can lead to functional repercussions (decreased strength and physical function) and reduced calories that the body burns daily. Naturally, this is especially important in people suffering from sarcopenia before BS, and it occurs more frequently in postmenopausal women. Despite this is known, specific protein intake recommendations after BS have not yet been defined based on scientific evidence. In this context, the first part of our proposal will assess the effect of two levels of protein supplementation: standard (S-PS) versus high (H-PS) on changes in a) body composition, b) energy expenditure, c) metabolic flexibility d) the physical condition during weight loss that follows BS. In addition, in patients with H-PS, the added effect of a physical exercise program, carried out with a personal trainer (professional of sports medicine trainer) virtually, will be evaluated. Protein supplementation and the virtual exercise program will be done during the 4 months following BS, and the results will be studied at 4, 8, and 12 months. Once the results have been defined, it is essential to transfer the recommendations to the real world. In a second part, and to achieve knowledge transfer to clinical practice, the investigators will explore the key elements that influence patient experience (XPA).


Description:

Obesity is considered a chronic disease that increases the risk of developing diseases that reduce life expectancy. The treatment of obesity is complex. However, treatments based exclusively on dietary changes have not shown long-term efficacy especially in people with severe obesity. In contrast, in this group of people bariatric surgery (BS) has shown good long-term results in weight loss and maintenance. These changes are accompanied by significant improvements in health, improved quality of life, and reduced mortality. However, the changes in the digestive system created by BS and the high level of dietary restriction, affect the nutritional status and require a proper supplementation of vitamins and minerals during the follow-up. Intense weight loss during the first few months, coupled with an insufficient amount of protein in the diet, can lead to a loss of muscle mass. Excessive muscle loss during the short-term period can lead to functional repercussions (decreased strength and physical function) and reduced calories that the body burns daily. Naturally, this is especially important in people suffering from sarcopenia before BS, and it occurs more frequently in postmenopausal women. Despite this is known, specific protein intake recommendations after BS have not yet been defined based on scientific evidence. In this context, the first part of our proposal will assess the effect of two levels of protein supplementation: standard (SP-S) versus high (SP-A) on changes in a) body composition, b) energy expenditure, c) metabolic flexibility d) the physical condition during weight loss that follows BS. In addition, in patients with SP-Alta, the added effect of a physical exercise program, carried out with a personal trainer (professional of sports medicine trainer) virtually, will be evaluated. Protein supplementation and the virtual exercise program will be done during the 4 months following CO, and the results will be studied at 4, 8, and 12 months. Once the results have been defined, it is essential to transfer the recommendations to the real world. In a second part, and to achieve knowledge transfer to clinical practice, the investigators will explore the key elements that influence patient experience (XPA). The investigators will define indicators to assess it, especially those that are related to adherence to nutritional recommendations and to changes in lifestyle. The investigators are currently in the recruitment phase of the study. I have studied the necessary elements, ambitions and included the components that will help to define the dietary and lifestyle recommendations for our population. Aim to facilitate and define the performance of the professionals providing realistic, based on the XPA and in this way to improve the impact of the CO on health and quality of life. This is an ambitious and necessary study and includes all the component that will help define dietary and lifestyle recommendations for our population. It aims to facilitate and define the action of professionals provides realistic tools, based on XPA and thus improve the impact of BS on health and quality of life. Description of the population to study sedentary women, candidates for BS at our institution.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date June 30, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: women =45 years of age who meet CB criteria: Body mass index (BMI) =40.0 kg / m2 or between 35.0 and 39.9 kg / m2 with comorbidities (metabolic diseases, cardiorespiratory diseases), sedentary lack of regular physical activity: <30 minutes / day and <3 days / week). Exclusion Criteria: - presence of severe joint disease, severe liver disease, history of cardiovascular event or known heart disease, renal failure (defined as a FG <30 ml / min), type 1 or type 2 diabetes with HbA1c> 10%, being treated with drugs that may affect body composition (such as corticosteroids), exercise muscle strength-endurance regularly (more than 2 times / week), have previously undergone obesity surgery.

Study Design


Intervention

Dietary Supplement:
Protein Supplementation
protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT

Locations

Country Name City State
Spain Hospital Clinic Barcelona Barcelona

Sponsors (3)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona Garmin International, Institut Nacional d'Educacio Fisica de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary effect of PS and PA on Changes in fat mass and Fat free mass (kg) change from baseline in DEXA values 4 months after BS
Primary effect of PS and PA on Changes in fat mass and Fat free mass (kg) change from baseline in DEXA values 8 months after BS
Primary effect of PS and PA on Changes in fat mass and Fat free mass (kg) change from baseline in DEXA values 12 months after BS
Primary effect of PS and PA on resting energy expenditure (REE) (Kcal/ day) change from baseline in estimated REE from indirect calorimety 4 months after BS
Primary effect of PS and PA on resting energy expenditure (REE) (Kcal/ day) change from baseline in estimated REE from indirect calorimety 8 months after BS
Primary effect of PS and PA on resting energy expenditure (REE) (Kcal/ day) change from baseline in estimated REE from indirect calorimety 12 months after BS
Primary Strength changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip. 4 months after BS
Primary Strength changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip. 8 months after BS
Primary Strength changes from baseline on prediction of ne repetition máximum (1-RM) and hang grip. 12 months after BS
Primary Functionality changes from baseline on sit and stand 4 months after BS
Primary Functionality changes from baseline on sit and stand 8 months after BS
Primary Functionality changes from baseline on sit and stand 12 months after BS
Primary Metabolic flexibility - oxidation of substrates: VO2 peak change in VO2 peak measured by Ergocard during half-effort test 4 months after BS
Primary Metabolic flexibility - oxidation of substrates: VO2 peak change in VO2 peak measured by Ergocard 8 months after BS
Primary Metabolic flexibility - oxidation of substrates: VO2 peak change in VO2 peak measured by Ergocard during half-effort test 12 months after BS
Primary Respiratory quotient change in RQ determined by Ergocard during half-effort test 4 months after BS
Primary Respiratory quotient change in RQ determined by Ergocard during half-effort test 8 months after BS
Primary Respiratory quotient change in RQ determined by Ergocard during half-effort test 12 months after BS
Primary Fat oxidation (FatMax) during during half-effort test Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min) 4 months after BS
Primary Fat oxidation (FatMax) during during half-effort test Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min) 8 months after BS
Primary Fat oxidation (FatMax) during during half-effort test Time to spend to reach the cross over pony for RQ=1 determined by Ergocard during half-effort test (min) 12 months after BS
Primary Adherence to PS (BCAA biomarker) serum change in BCAA (mcg) 4 months after BS
Primary Adherence to PS (BCAA biomarker) serum change in BCAA (mcg) 8 months after BS
Primary Adherence to PS (BCAA biomarker) serum change in BCAA (mcg) 12 months after BS
Primary Adherence to PS (urinary nitrogen 24hs.) Nitrogen (mg) values quantified in 24hs urine 4 months after BS
Primary Adherence to PS (urinary nitrogen 24hs.) Nitrogen (mg) values quantified in 24hs urine 8 months after BS
Primary Adherence to PS (urinary nitrogen 24hs.) Nitrogen (mg) values quantified in 24hs urine 12 months after BS
Primary Understand patients' priorities and the "painful points" of the care process. Explore the magnitude of these "painful points." This should make it possible to prioritize the areas to be evaluated. Test assessment tools identify by focus group patient reported outcomes by cualitative study 12 months after BS
Secondary Changes in BMI weight and height will be combined to report BMI in kg/m^2 4 months after BS
Secondary Changes in BMI weight and height will be combined to report BMI in kg/m^2 8 months after BS
Secondary Changes in BMI weight and height will be combined to report BMI in kg/m^2 12 months after BS
Secondary Insulin sensitivity (HOMA-IR) fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in 4 months after BS
Secondary Insulin sensitivity (HOMA-IR) fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in 8 months after BS
Secondary Insulin sensitivity (HOMA-IR) fasting glucose (mg) and insulin (miliunits/ liter) will be combined to report Insulin sensitivity in 12 months after BS
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