Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619028
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
External Body Weight Effects on Body Weight in Adults With Grade II and III Obesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of the Use of External Body Weight in the Regulation of Body Weight Body Composition and Analytical Parameters in Adults With Grade II and III Obesity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obesity is a growing problem in industrialized societies This condition is associated with an increase in metabolic and cardiovascular diseases Its cause is multifactorial influenced by the environment excessive calorie consumption insufficient physical activity sedentary lifestyle and alterations in energy metabolism
In this context the hormone leptin responsible for regulating appetite and body weight presents resistance in people with obesity altering the metabolic balance Recent research has explored the concept of the gravitostat a system that responds to the mechanical stimulus of standing upright as a promising approach in the regulation of body weight Animal and human studies have shown positive results in weight loss and body recomposition using this system However more research is needed to evaluate the clinical applicability and effectiveness of the gravitostat in the management of obesity
For this reason the present study is proposed with a prospective longitudinal controlled design in the use of external body weight where the patients are their own control intrasubject controlled study during 4 weeks with a previous control period of 4 weeks and a follow-up of 4 weeks The proposed objectives are to analyze the effectiveness of the use of external weight in the regulation of body weight body composition and analytical parameters in people with grade II and III obesity In this way to analyze the clinical applicability of the gravitostat in the management of patients with this metabolic pathology
In this context the hormone leptin responsible for regulating appetite and body weight presents resistance in people with obesity altering the metabolic balance Recent research has explored the concept of the gravitostat a system that responds to the mechanical stimulus of standing upright as a promising approach in the regulation of body weight Animal and human studies have shown positive results in weight loss and body recomposition using this system However more research is needed to evaluate the clinical applicability and effectiveness of the gravitostat in the management of obesity
For this reason the present study is proposed with a prospective longitudinal controlled design in the use of external body weight where the patients are their own control intrasubject controlled study during 4 weeks with a previous control period of 4 weeks and a follow-up of 4 weeks The proposed objectives are to analyze the effectiveness of the use of external weight in the regulation of body weight body composition and analytical parameters in people with grade II and III obesity In this way to analyze the clinical applicability of the gravitostat in the management of patients with this metabolic pathology
Detailed Description:
BACKGROUND Obesity is one of the most prevalent and booming health and social problems in recent decades in industrialized societies Obesity rates in European countries such as the United Kingdom Germany France and Spain fluctuate between 23 and 29 in the adult population according to the World Health Organization WHO These values increase to 424 27 and 31 in the United States Canada and Australia respectively considering data from the last 5 years from the main health agencies of these countries making it a social and public health problem
The etiopathogenesis of this condition is multifactorial the obesogenic characteristics of the environment can influence gene expression conditioning the development of obesity Increased caloric intake influenced by high-fat diets Westerns39 diet the absence or insufficiency of physical activity and alterations in energy metabolism seem to be the three fundamental factors contributing to the development of obesity Moreover these factors seem to play a major role in the development of other metabolic entities such as hypertension dyslipidemia and insulin resistance or type II diabetes which together with central obesity make up the metabolic syndrome This clinical entity doubles the risk of coronary and cerebrovascular disease increases the risk of diabetes fivefold and increases all-cause mortality by 50 In parallel to the risk factors listed above some studies highlight the role of a sedentary lifestyle as a factor independent of physical activity in contributing to the development of metabolic pathology Not only the absence of low moderate or high intensity physical activity has been correlated with the development of metabolic syndrome but also the increase in time spent in sedentary activities with an odds ratio of 238
These intrinsic and extrinsic factors seem to interact and condition each other altering homeostatic and physiological processes in obese individuals
Since its discovery and description in the 1990s by Friedman leptin has been the most important hormonal factor in the regulation and control of caloric intake and metabolism and consequently of body weight and composition Its peripheral production at the level of white fat tissue and its hypothalamic effects decrease in orexic neuronal activity and conditioning of dopaminergic reward circuits condition the individual39s response to food regulating satiety and intake
Evidence shows that this mechanism is altered in people with obesity where excessive leptin production due to increased concentrations of fat tissue and consequently high serum concentrations condition central and peripheral sensitivity to this hormone generating in the long run lower response efficiency giving rise to the term leptin resistance This resistance seems to modify the hypothalamic satiety signal as well as the dopaminergic circuits associated with food intakepredisposing to the appearance or increase of metabolic pathology especially obesity This dysregulation in caloric intake appears without alterations in the production and function of ghrelin a hormone produced in the stomach associated with hunger
Recent research has proposed a second system of body weight homeostasis associated with the mechanical stimulus of standing upright coined the term gravitostat
Studies in mice and in humans show promising results in the regulation of body weight and fat percentage by this mechanical system These investigations have shown significant reductions in both parameters when external weight is added to the study subjects generating modifications in food intake and caloric expenditure These adaptations have been tested independently of leptin resistance or the lack of leptin receptors thus demonstrating the existence of an independent homeostatic regulation pathway These changes have been shown to be significant only in obese subjects whereas in normopese subjects who show greater sensitivity to leptin the changes produced by the increased load do not appear to be significant Regarding body recomposition these studies seem to indicate a maintenance of muscle mass without experiencing significant losses as in other contexts of caloric deficit thus prioritizing the loss of white fat tissue especially visceral as a mechanism of weight regulation
Some studies justify this action by the production of fibroblast growth factors FGF produced by the osteocytes specifically the factor FGF21 associated with the hypothalamic receptor FGFR1c The triplication in the serum quantities of FGF21 factor by hepatic expression in subjects exposed to body weight seems to justify the increase in fat mobilization and oxidation as well as the loss of body weight which despite the catabolic context does not affect muscle mass In any case the results do not yet seem to be conclusive since at supraphysiological loads of FGF21 the action of weight loss is mitigated probably indicating a regulation by the FGFR1c receptor mediated in part by one or more other factors This could be a key factor in the lack of effectiveness in normopese individuals
Some stuides show how the increased load during the prepubertal period in rats reduces the expression of hormones associated with growth IGF-1 and GHGH as a homeostatic mechanism to control sudden weight gain Similarly down-regulation of ghrelin receptors at the hypothalamic level is observed leading to a decrease in caloric intake Other adaptations that could explain the physiological mechanism of body homeostasis in this case during growth
With respect to analytical parameters the only clinical trial carried out in humans only shows significant reductions in LDL and leptin the results are inconclusive for the other parameters studied
Taking this into consideration some evidence observed a bidirectional regulation with increases in body weight and fat mass in subjects with the sudden decrease in load The lack of follow-up in human studies4 does not allow extrapolation of these results At the clinical level this regulation could justify weight and essentially fat gain after liposuction interventions6 or other contexts of abrupt weight loss or dietary patterns with aggressive caloric restriction In this case both homeostatic systems would influence on the one hand the gravitostat would increase food intake and the decrease in adipose tissue and the conditioned reduction in leptin production would decrease anorexic signals predisposing the subjects to have more frequent and calorically dense intakes
The results presented by some reserchers are promising in the development of new tools to help patients with obesity despite this the short duration of the intervention and the lack of follow-up of the patients the lack of consistent changes in the analytical analysis the performance only in young and moderately obese patients as well as the high demand of the intervention protocol and the sudden gain in body weight after the intervention in basic studies make further research necessary to prove the applicability usefulness and effectiveness of the gravitostat as a therapeutic tool as well as the high demands of the intervention protocol and the sudden gain of body weight after the intervention in basic studies make it necessary to carry out further research to prove the applicability usefulness and effectiveness of the gravitostat as a therapeutic tool in patients with obesity
For this reason the present doctoral thesis proposes an intrasubject controlled study for a period of 12 weeks 4 control 4 intervention and 4 follow-up in patients with grade II and III obesity During the intervention period the participants will be exposed to an external load by means of a weighted vest of 10 of their body weight for a minimum of 8 hours per day for 4 weeks In the first phase of the study participants will be followed without changes in their lifestyle as a control During the intervention they will be instructed to perform their usual activities with the vest without further alterations in their lifestyle
For this study accepting an alpha risk of 005 and a beta risk of less than 02 in a unilateral contrast 24 patients are required to detect a difference equal to or greater than 015 unit A common standard deviation of 14 and a correlation between the first and second measurement of 099 according to literature is assumed A loss rate of 10 is assumed Patients will be recruited from the endocrinology service of the Hospital Universitario Parc Taulí
The etiopathogenesis of this condition is multifactorial the obesogenic characteristics of the environment can influence gene expression conditioning the development of obesity Increased caloric intake influenced by high-fat diets Westerns39 diet the absence or insufficiency of physical activity and alterations in energy metabolism seem to be the three fundamental factors contributing to the development of obesity Moreover these factors seem to play a major role in the development of other metabolic entities such as hypertension dyslipidemia and insulin resistance or type II diabetes which together with central obesity make up the metabolic syndrome This clinical entity doubles the risk of coronary and cerebrovascular disease increases the risk of diabetes fivefold and increases all-cause mortality by 50 In parallel to the risk factors listed above some studies highlight the role of a sedentary lifestyle as a factor independent of physical activity in contributing to the development of metabolic pathology Not only the absence of low moderate or high intensity physical activity has been correlated with the development of metabolic syndrome but also the increase in time spent in sedentary activities with an odds ratio of 238
These intrinsic and extrinsic factors seem to interact and condition each other altering homeostatic and physiological processes in obese individuals
Since its discovery and description in the 1990s by Friedman leptin has been the most important hormonal factor in the regulation and control of caloric intake and metabolism and consequently of body weight and composition Its peripheral production at the level of white fat tissue and its hypothalamic effects decrease in orexic neuronal activity and conditioning of dopaminergic reward circuits condition the individual39s response to food regulating satiety and intake
Evidence shows that this mechanism is altered in people with obesity where excessive leptin production due to increased concentrations of fat tissue and consequently high serum concentrations condition central and peripheral sensitivity to this hormone generating in the long run lower response efficiency giving rise to the term leptin resistance This resistance seems to modify the hypothalamic satiety signal as well as the dopaminergic circuits associated with food intakepredisposing to the appearance or increase of metabolic pathology especially obesity This dysregulation in caloric intake appears without alterations in the production and function of ghrelin a hormone produced in the stomach associated with hunger
Recent research has proposed a second system of body weight homeostasis associated with the mechanical stimulus of standing upright coined the term gravitostat
Studies in mice and in humans show promising results in the regulation of body weight and fat percentage by this mechanical system These investigations have shown significant reductions in both parameters when external weight is added to the study subjects generating modifications in food intake and caloric expenditure These adaptations have been tested independently of leptin resistance or the lack of leptin receptors thus demonstrating the existence of an independent homeostatic regulation pathway These changes have been shown to be significant only in obese subjects whereas in normopese subjects who show greater sensitivity to leptin the changes produced by the increased load do not appear to be significant Regarding body recomposition these studies seem to indicate a maintenance of muscle mass without experiencing significant losses as in other contexts of caloric deficit thus prioritizing the loss of white fat tissue especially visceral as a mechanism of weight regulation
Some studies justify this action by the production of fibroblast growth factors FGF produced by the osteocytes specifically the factor FGF21 associated with the hypothalamic receptor FGFR1c The triplication in the serum quantities of FGF21 factor by hepatic expression in subjects exposed to body weight seems to justify the increase in fat mobilization and oxidation as well as the loss of body weight which despite the catabolic context does not affect muscle mass In any case the results do not yet seem to be conclusive since at supraphysiological loads of FGF21 the action of weight loss is mitigated probably indicating a regulation by the FGFR1c receptor mediated in part by one or more other factors This could be a key factor in the lack of effectiveness in normopese individuals
Some stuides show how the increased load during the prepubertal period in rats reduces the expression of hormones associated with growth IGF-1 and GHGH as a homeostatic mechanism to control sudden weight gain Similarly down-regulation of ghrelin receptors at the hypothalamic level is observed leading to a decrease in caloric intake Other adaptations that could explain the physiological mechanism of body homeostasis in this case during growth
With respect to analytical parameters the only clinical trial carried out in humans only shows significant reductions in LDL and leptin the results are inconclusive for the other parameters studied
Taking this into consideration some evidence observed a bidirectional regulation with increases in body weight and fat mass in subjects with the sudden decrease in load The lack of follow-up in human studies4 does not allow extrapolation of these results At the clinical level this regulation could justify weight and essentially fat gain after liposuction interventions6 or other contexts of abrupt weight loss or dietary patterns with aggressive caloric restriction In this case both homeostatic systems would influence on the one hand the gravitostat would increase food intake and the decrease in adipose tissue and the conditioned reduction in leptin production would decrease anorexic signals predisposing the subjects to have more frequent and calorically dense intakes
The results presented by some reserchers are promising in the development of new tools to help patients with obesity despite this the short duration of the intervention and the lack of follow-up of the patients the lack of consistent changes in the analytical analysis the performance only in young and moderately obese patients as well as the high demand of the intervention protocol and the sudden gain in body weight after the intervention in basic studies make further research necessary to prove the applicability usefulness and effectiveness of the gravitostat as a therapeutic tool as well as the high demands of the intervention protocol and the sudden gain of body weight after the intervention in basic studies make it necessary to carry out further research to prove the applicability usefulness and effectiveness of the gravitostat as a therapeutic tool in patients with obesity
For this reason the present doctoral thesis proposes an intrasubject controlled study for a period of 12 weeks 4 control 4 intervention and 4 follow-up in patients with grade II and III obesity During the intervention period the participants will be exposed to an external load by means of a weighted vest of 10 of their body weight for a minimum of 8 hours per day for 4 weeks In the first phase of the study participants will be followed without changes in their lifestyle as a control During the intervention they will be instructed to perform their usual activities with the vest without further alterations in their lifestyle
For this study accepting an alpha risk of 005 and a beta risk of less than 02 in a unilateral contrast 24 patients are required to detect a difference equal to or greater than 015 unit A common standard deviation of 14 and a correlation between the first and second measurement of 099 according to literature is assumed A loss rate of 10 is assumed Patients will be recruited from the endocrinology service of the Hospital Universitario Parc Taulí
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None