CARLOTA
The impact of a fat-rich preload before a carbohydrate-rich meal on glucose homeostasis in patients without diabetes after sleeve gastrectomy: A proof-of-concept, randomised, open-label, crossover study.
The CARLOTA study
Study title
People without diabetes who have had weight loss surgery can develop symptoms due to low blood glucose levels (hypoglycaemia) a few hours after eating a sugary meal. Common symptoms include dizziness, sweating, shaking, hunger and drowsiness. Symptoms happen when food passes too quickly into the intestines due to changes after surgery. Glucose from food is absorbed quickly and too much insulin is released.
Previous studies in people without surgery have shown that eating a fat-rich snack half hour before a sugary meal can change how fast the sugary meal leaves the stomach, how fast glucose is absorbed and how much insulin is released.
In this study we are investigating the effect of eating 28g of nuts half hour before a sugar-rich meal and look at how this will change blood glucose and insulin levels. We will also add 1g of paracetamol into the meal and this will help us asses how quick food leaves the stomach and enters the small intestine with and without eating a fat-rich snack.
Background
The aim of the study is to explore if eating a fat-rich snack before a sugar-rich meal could be a treatment option for post-meal hypoglycaemia after weight loss surgery.
Study aims
This study is a proof-of-concept, randomised open label, cross over study, conducted in male and female participants (without diabetes) who have Sleeve Gastrectomy (SG).
There are a total of three study visits which will take place at the Leicester Diabetes Centre. At visit one participants will be randomised to one of the following two treatment sequences:
Group one: will have the 28g of nuts with 80ml of water (preload) 30 minutes before the milkshake (with 1g dissolvable paracetamol).
Group two: will have 100ml of water and then the milkshake (with 1g dissolvable paracetamol).
Study summary
Study progress
This study is currently open to recruitment.
Recruitment end date: August 2022
Funder: Health Education England East Midlands/NIHR Biomedical Research Centre.
Sponsor: University of Leicester
Funding and sponsorship
None yet
Study publications
Principle Investigator: Dr Dimitris Papamargaritis
Trial Manager: Mamta Joshi
For more information about The CARLOTA study, please contact us on the below:
Phone: 0116 258 4023
Research team