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New treatment option for Obesity
Official title Gut Hormones and Roux en Y Gastric Bypass
ClinicalTrials.gov ID: NCT01945840
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of...
- 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.
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, Greater London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Greater London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.