Efficacy and Tolerance of Liraglutide for Weight Loss in Obese Type 2 Diabetic Hemodialysis Patients

  • STATUS
    Recruiting
  • End date
    Jul 17, 2022
  • participants needed
    30
  • sponsor
    Groupe Hospitalier Paris Saint Joseph
Updated on 24 March 2021

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 2.6 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.

Details
Condition NIDDM, adiposity, Hemodialysis, Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Liraglutide
Clinical Study IdentifierNCT04529278
SponsorGroupe Hospitalier Paris Saint Joseph
Last Modified on24 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: type 2 diabetes or Diabetes Mellitus Type 2 or diabetes type 2 or type 2 diabetes mellitus or Diabetes Mellitus, Type 2 or adiposity or noninsulin-dep...?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or Hemodialysis or type 2 diabetes mellitus or diabetes type 2 or Diabetes Mellitus Type 2 or adiposity or type ii diabetes ...?
Do you have any of these conditions: Obesity or type ii diabetes or diabetes type 2 or NIDDM or noninsulin-dependent diabetes mellitus or Diabetes Mellitus, Type 2 or Diabetes Mellitus Ty...?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or NIDDM or Diabetes Mellitus Type 2 or type ii diabetes or Obesity or noninsulin-dependent diabetes mellitus or adiposity o...?
Do you have any of these conditions: noninsulin-dependent diabetes mellitus or adiposity or Diabetes Mellitus, Type 2 or type ii diabetes or NIDDM or type 2 diabetes mellitus or type 2 di...?
Patient aged 18 and <70
Patient on hemodialysis for more than 6 months
Type 2 diabetic patient
Patient with a BMI> 30 kg / m2 with a Temporary Contraindication for kidney transplant for renal transplant due to overweight by his graft center
Patient affiliated to a health insurance plan
French speaking patient
Patient having given free, informed and written consent

Exclusion Criteria

Patient with a Temporary Contraindication for kidney transplant for a cause other than overweight
Patient with personal or family history of thyroid medullary cancer
Patient with a history of acute or chronic pancreatitis
Patient who has already had hypersensitivity to liraglutide (or to any other component of the product)
Patient who has already had a severe digestive intolerance to taking GLP-1 receptor agonists (such as exenatide or lixisenatide)
Patient already included in an interventional risk research protocol (RIPH1)
Pregnant or lactating woman
Patient under guardianship or curatorship
Patient deprived of liberty
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