Proglucagon peptide secretion profiles in type 2 diabetes before and after bariatric surgery: 1-year prospective study.
Kleopatra Alexiadou, Joyceline Cuenco, James Howard...
https://pubmed.ncbi.nlm.nih.gov/32209584Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID01945840
Gut Hormones and Roux-en-Y Gastric Bypass Surgery Studying Their Role in Weight Loss and Metabolic Effects in Obesity and Type 2 Diabetes
Led by Imperial College London · Updated on 2021-04-20
190
Participants Needed
1
Research Sites
787 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether the combined increase of certain gut hormones—glucagon-like peptide-1 (GLP-1), oxyntomodulin, and peptide YY (PYY)—after Roux-en-Y gastric bypass surgery is responsible for many of the surgery's positive effects. These effects include better blood sugar control, higher energy use, less food intake, weight loss, reduced preference for high-calorie foods, and less brain activity in response to food cues. The study focuses on adults aged 18 to 70 years with obesity and type 2 diabetes or impaired glucose regulation. Participants will undergo Roux-en-Y gastric bypass surgery and may receive infusions of gut hormones or placebo to assess their combined impact. Additionally, some will follow a very low calorie diet. The study examines the metabolic changes caused by these interventions and how they relate to the surgery's benefits. During the study, researchers will monitor participants' weight loss over four weeks and evaluate metabolic and behavioral changes. Assessments include blood tests, brain imaging, and food preference evaluations. The study also tracks safety and adherence, ensuring participants meet eligibility and complete necessary follow-ups throughout the study period.
CONDITIONS
Official Title
Gut Hormones and Roux en Y Gastric Bypass
Who Can Participate
Age: 18Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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.
- Diabetes should be stable and well controlled with either diet or one oral hypoglycaemic agent.
- HbA1c 4.9% or 74.9 mmol/mol.
You will not qualify if you...
- History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, that could interfere with the study or cause harm.
- No access to a telephone at home or other factors likely to affect reliable participation.
- Pregnancy or breastfeeding.
- Smokers.
- Unable to maintain adequate contraception during the study and for one month after.
- History of hypersensitivity to components of the subcutaneous infusions.
- Donated blood during the past 3 months or plans to do so before study end.
- Currently on insulin treatment.
- Uncontrolled hypertension.
- Any co-morbidity compromising study validity or safety, such as heart failure or cardiovascular disease.
- Use of anti-coagulants like warfarin and factor Xa inhibitors (cannot undergo adipose tissue biopsy).
- Unable to give informed consent.
- Previous bariatric surgery.
- Unable to undergo fMRI due to claustrophobia, metal implants or devices, significant brain abnormalities, or other MRI contraindications.
AI-Screening
AI-Powered Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital
London, Greater London, United Kingdom
Actively Recruiting
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Research Team
T
Tricia Tan, MBChB MRCP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
Frequently Asked Questions
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Published Research Related To This Trial
Roux-en-Y Gastric Bypass Increases Glycemic Variability and Time in Hypoglycemia in Patients With Obesity and Prediabetes or Type 2 Diabetes: A Prospective Cohort Study.
Ibiyemi Ilesanmi, George Tharakan, Kleopatra Alexiadou...
https://pubmed.ncbi.nlm.nih.gov/33334806Combined GLP-1, Oxyntomodulin, and Peptide YY Improves Body Weight and Glycemia in Obesity and Prediabetes/Type 2 Diabetes: A Randomized, Single-Blinded, Placebo-Controlled Study.
Preeshila Behary, George Tharakan, Kleopatra Alexiadou...
https://pubmed.ncbi.nlm.nih.gov/31177183Tripeptide gut hormone infusion does not alter food preferences or sweet taste function in volunteers with obesity and prediabetes/diabetes but promotes restraint eating: A secondary analysis of a randomized single-blind placebo-controlled study.
Preeshila Behary, Haya Alessimii, Alexander D Miras...
https://pubmed.ncbi.nlm.nih.gov/36811311The postprandial secretion of peptide YY1-36 and 3-36 in obesity is differentially increased after gastric bypass versus sleeve gastrectomy.
Anna M Kowalka, Kleopatra Alexiadou, Joyceline Cuenco...
https://pubmed.ncbi.nlm.nih.gov/36345253The Metabolomic Effects of Tripeptide Gut Hormone Infusion Compared to Roux-en-Y Gastric Bypass and Caloric Restriction.
Ben Jones, Caroline Sands, Kleopatra Alexiadou...
https://pubmed.ncbi.nlm.nih.gov/34460933