Gut Hormones and Roux en Y Gastric Bypass

  • STATUS
    Recruiting
  • End date
    Oct 31, 2028
  • participants needed
    190
  • sponsor
    Imperial College London
Updated on 27 April 2021

Summary

The purpose of this study is to assess whether the changes in gut hormones seen following Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen post-operatively.

Description

This study is designed to investigate whether chronic elevation of glucagon-like peptide-1 (GLP-1), oxyntomodulin and peptide YY (PYY) in combination is responsible for the majority of the metabolic effects of Roux-en-Y gastric bypass (RYGB) including improved glycaemia, increased energy expenditure, reduced food intake, weight loss, reduced preference for high calorie foods and reduced activation in brain reward areas in response to visual food cues.

Details
Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, Diabetes Mellitus, Diabetes Mellitus Types I and II, Diabetes Prevention, Diabetes (Pediatric), adiposity, Obesity, Obesity, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Very low calorie diet, Placebo infusion, Roux en Y Gastric Bypass Surgery, Gut hormone infusion
Clinical Study IdentifierNCT01945840
SponsorImperial College London
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 - 70 years
Male or female
Eligible for bariatric surgery under the NHS
Diagnosed with impaired glucose regulation or type 2 diabetes, according to WHO 2011 criteria
Those with diabetes should be stable and well controlled with either diet or one oral hypoglycaemic agent
HbA1c 9.0% or 74.9 mmol/mol

Exclusion Criteria

History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer
Without access at home to a telephone or other factor likely to interfere with ability to participate reliably in the study
Pregnancy or breastfeeding
Smokers
Unable to maintain adequate contraception for the duration of the study and for one month afterwards
History of hypersensitivity to any of the components of the subcutaneous infusions
Donated blood during the preceding 3 months or intention to do so before the end of the study
Insulin treatment
Uncontrolled hypertension
Any other co-morbidity that would compromise the validity of the study or the safety of the participant such as heart failure, clinically apparent cardiovascular disease
Volunteers on anti-coagulants such as warfarin and factor Xa inhibitors will not undergo adipose tissue biopsy
Unable to give informed consent
Previous bariatric surgery
Unable to undergo fMRI due to
Claustrophobia
Pacemaker, metal implant, clips, implanted device, shrapnel or bullet, metal in eyes that precludes magnetic resonance imaging
Significant structural abnormality on magnetic resonance brain scan
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