Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery
Ključne besede
Povzetek
Opis
With the growing number of RYGB operated subjects the attention on complications such as postprandial hyperinsulinemic hypoglycemia (PHH) has increased. PHH is characterized by increased glycemic variability and hypoglycemic episodes occurring 2-3 hours after a meal together with a markedly increase in insulin and glucagon-like-peptide 1 (GLP-1) levels. Symptoms vary from dizziness and palpitations to confusion, loss of consciousness and convulsions. At present there are few treatment options available for RYGB patients with PHH and most of them rely on dietary changes that are difficult to adhere to.
Pasireotide has been shown to reduce hypoglycemia in RYGB operated subjects with PHH, but often leads to increased hyperglycemia as well.
The purpose of the study is to investigate two doses of pasireotide in RYGB operated subjects with PHH.
Each subject will undergo two meal tolerance test (MTT) preceded by either 75 µg or 150 µg of pasireotide. Blood samples will be collected throughout the meal test at predefined time points and will be analyzed for glucose, insulin, C-peptide, GLP-1 and glucagon levels.
Datumi
| Nazadnje preverjeno: | 06/30/2018 |
| Prvič predloženo: | 04/18/2018 |
| Predviden vpis oddan: | 04/18/2018 |
| Prvič objavljeno: | 05/01/2018 |
| Zadnja posodobitev oddana: | 07/01/2018 |
| Zadnja posodobitev objavljena: | 07/04/2018 |
| Dejanski datum začetka študija: | 05/31/2018 |
| Predvideni datum primarnega zaključka: | 07/31/2018 |
| Predvideni datum zaključka študije: | 10/31/2018 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: Pasireotide 0.3 MG/ML
Diagnostic Test: Meal tolerance test (MTT)
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: Pasireotide75 75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT) | |
| Experimental: Pasireotide150 150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT) |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | Female |
| Sprejema zdrave prostovoljce | Da |
| Merila | Inclusion Criteria: - RYGB operated patients with documented hypoglycemia (blood glucose <3.9 mmol/L) who have previously completed the study 'Treatment of hypoglycemia following gastric bypass surgery' (HypoGB2015) - Hemoglobin > 7,3 mmol/L - Negative human chorionic gonadotropin (hCG) urine test - Females of reproductive age: use of safe contraception Exclusion Criteria: - Treatment for cardiovascular disease - Treatment with antipsychotic medication - Treatment for thyroid disease - Prior medical treatment of postprandial hyperinsulinemic hypoglycemia - Prior allergic reactions to the study medicine |
Izid
Primarni izidni ukrepi
1. Changes in glucose (mmol/L) in response to a meal tolerance test (MTT) [From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
Ukrepi sekundarnega rezultata
1. Heart rate [From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
2. Serum insulin levels [From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
3. Serum C-peptide levels [From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
4. Plasma glucagon levels [From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
5. Plasma GLP-1 levels [From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
6. Blood pressure [From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion]
