Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04529278
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-14
First Post:
2020-08-21
Brief Title:
Efficacy and Tolerance of Liraglutide for Weight Loss in Obese Type 2 Diabetic Hemodialysis Patients
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Efficacy and Tolerance of Liraglutide for Weight Loss in Obese Type 2 Diabetic Hemodialysis Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
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:
LIRADIAL
Brief Summary:
Diabetes is the second leading cause of end stage renal disease in France 22 in the 2016 REIN register In hemodialysis its prevalence is higher between 30-40 depending on the study Associated with type 2 diabetes a large number of patients present with overweight body mass index or BMI 25 kg m2 which can lead to a temporary contraindication to kidney transplant by the surgeon or even definitive once BMI is over 30 kg m2 Indeed above this threshold patients are exposed to an increased risk of surgical complications wall infections suture release hospitalizations and potentially transplant failure A recent study based on the Kidney Registry showed that patients with a BMI 31 kg m2 were more likely to stay on dialysis than to benefit from a transplant whereas for each decrease of 1 kg m2 of BMI there is a 9-11 increase in the likelihood of being transplanted The management of obesity in dialysis patients is important for reducing cardiovascular risks but also because it increases the chances of access to transplantation However current weight loss programs are disappointing The changes in hygiene and diet rules integrated into a specialized monitoring program only allow a weight loss of 2 to 8 in 24 months for half of the patients Bariatric surgery is of course a more effective alternative but with a 10 risk of postoperative complications
Glucagon-Like Peptide 1 aGLP1 analogues are a new class of antidiabetic drugs that have revolutionized the management of type 2 diabetes In fact they combine efficacy on glycemic control but also on weight loss They are used in obese non-diabetic people in some countries with a reduction in weight of up to 10 to 15 with certain molecules In addition they have shown an effect on reducing cardiovascular events in diabetics including with Chronic Kidney Disease CKD 3-4 AGPL1 are well tolerated with side effects mainly of digestive tropism such as nausea or vomiting Exceptionally these effects can occur from the first injection requiring permanent discontinuation of treatment In 20 of cases these side effects can appear in the first weeks They gradually fade spontaneously or after symptomatic treatment and allow titration of the drug
AGLP1 is currently contraindicated in patients with reduced renal function that is when the glomerular filtration rate GFR is 15 ml min MRC stage 5-5D because this population specific was excluded from the originator studies However aGLP1 are small peptides that are not eliminated by the kidneys Their elimination takes place through the general catabolism of proteins To date 2 publications have evaluated the safety profile and efficacy of an aGLP1 liraglutide Victoza in diabetic dialysis patients These studies showed that the 24 hour plasma concentration of liraglutide increased by 50 over the long term The safety profile was acceptable with as expected a predominance of gastrointestinal effects in the first weeks of treatment such as nausea vomiting The authors suggest an adjustment of the dosages and a longer titration period to limit side effects However treatment with aGPL1 is effective with better glycemic control and an average weight loss of 26 kg over a period of 3 months Studies show that weight loss under liraglutide continues beyond 3 months with possible losses between 4 and 8 kg at 6 months and 12 months of treatment followed 12 Liraglutide Victoza is the analogue of GPL1 for which we have a sufficiently long follow-up 10 years on its effectiveness and its short and long-term side effects
The main objective of this project in type 2 diabetic patients on dialysis as a temporary contraindication for transplant due to overweight is on the one hand to study the effect of liraglutide on weight loss and control of diabetes and on the other hand to assess its tolerance in this population The expected benefit is to be able to facilitate registration on the waiting list and access to renal transplantation of these overweight patients without having to resort to more invasive methods such as bariatric surgery
Glucagon-Like Peptide 1 aGLP1 analogues are a new class of antidiabetic drugs that have revolutionized the management of type 2 diabetes In fact they combine efficacy on glycemic control but also on weight loss They are used in obese non-diabetic people in some countries with a reduction in weight of up to 10 to 15 with certain molecules In addition they have shown an effect on reducing cardiovascular events in diabetics including with Chronic Kidney Disease CKD 3-4 AGPL1 are well tolerated with side effects mainly of digestive tropism such as nausea or vomiting Exceptionally these effects can occur from the first injection requiring permanent discontinuation of treatment In 20 of cases these side effects can appear in the first weeks They gradually fade spontaneously or after symptomatic treatment and allow titration of the drug
AGLP1 is currently contraindicated in patients with reduced renal function that is when the glomerular filtration rate GFR is 15 ml min MRC stage 5-5D because this population specific was excluded from the originator studies However aGLP1 are small peptides that are not eliminated by the kidneys Their elimination takes place through the general catabolism of proteins To date 2 publications have evaluated the safety profile and efficacy of an aGLP1 liraglutide Victoza in diabetic dialysis patients These studies showed that the 24 hour plasma concentration of liraglutide increased by 50 over the long term The safety profile was acceptable with as expected a predominance of gastrointestinal effects in the first weeks of treatment such as nausea vomiting The authors suggest an adjustment of the dosages and a longer titration period to limit side effects However treatment with aGPL1 is effective with better glycemic control and an average weight loss of 26 kg over a period of 3 months Studies show that weight loss under liraglutide continues beyond 3 months with possible losses between 4 and 8 kg at 6 months and 12 months of treatment followed 12 Liraglutide Victoza is the analogue of GPL1 for which we have a sufficiently long follow-up 10 years on its effectiveness and its short and long-term side effects
The main objective of this project in type 2 diabetic patients on dialysis as a temporary contraindication for transplant due to overweight is on the one hand to study the effect of liraglutide on weight loss and control of diabetes and on the other hand to assess its tolerance in this population The expected benefit is to be able to facilitate registration on the waiting list and access to renal transplantation of these overweight patients without having to resort to more invasive methods such as bariatric surgery
Detailed Description:
None
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?:
None