ObesityFPSNCT01724060
Effects of Obesity Treatments on Food Preferences and Metabolism
An observational study of Obesity and Type 2 Diabetes Mellitus, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden both for patients and health systems alike. The surgical and medical treatments available for these conditions have improved significantly in the last two decades. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- How many people
- 80 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2012to Oct 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from the community or hospital care
Who may be able to join
- Adult patients with overweight and/or obesity (BMI ≥30 Kg/m2) who are eligible for obesity treatment based on NICE guidance or that are having non bariatric surgery or endoscopy.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Surrey County Hospital
Guildford
Imperial Weight Centre
London
About this study
Official title: The Effects of Current Treatments of Obesity on Food Preferences, Gut Hormones, Bile Acids and Hepatic Glucose Output in Humans.
Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden both for patients and health systems alike. The surgical and medical treatments available for these conditions have improved significantly in the last two decades. The investigators do not however know how these treatments compare to each other and how they act in the body to cause weight loss and diabetes improvements. The studies of this experiment are complementary to each other. They aim to answer related questions and will allow us to study how these treatments work and eventually develop safer and more effective therapies for obesity and diabetes.
Read the detailed description
The objective of this study is to investigate the effects of obesity surgical procedures and incretin therapies on food preferences, satiety, gut hormones, bile acids and hepatic glucose output in overweight and obese patients.
As part of routine care these patients will be seen by a dietician/diabetes specialist nurse (DSN) before and after intervention. Patients will be asked to prospectively complete food diaries on three consecutive days which are representative of their usual dietary intake. The first food diary will be completed three months to two weeks pre intervention. Another four food diaries will be completed post intervention: at one, three months, 6 months and one year. Total energy intake and macronutrient composition comparisons pre and post intervention will form the basis of our analysis.
20 patients in each group will undergo more detailed measurements of food intake, hunger, satiety, gut hormones and bile acids. The research protocol will be the similar to that previously published by the Department of Metabolic Medicine, Imperial College, London. Participants will be fasted for 12 hours overnight and will attend for the study on 5 occasions. On each occasion venous blood samples will be taken and visual analogue scores will be measured over a 3 hour period using previously published methodology Samples or sample containers will be anonymised before collection but will be traceable back to the individual patients. Urine will be collected once. A qualified medical doctor will insert a venepuncture cannula into the arm of the patient and 5ml blood will be withdrawn at baseline, 15, 30, 60, 90, 120, 150 and 180 minutes following ingestion of a standard 400kcal meal as below.
Ten patients in each group (different from those taking part in the meal studies) will undergo measurements of hepatic glucose output/insulin resistance through euglycaemic hyperinsulinaemic clamps (Metabolic Study). To ensure that acute caloric restriction does not affect insulin sensitivity, patients will be on a low calorie liquid diet for 4-14 days and 3-7 days after intervention to ensure that their weight is stable throughout the study. This diet is nutritious and contains all appropriate macronutrients. Such diets are frequently used as part of pre-obesity interventions to reduce weight and risk. Patients will provide the investigators with a detailed food diary of their food consumption for this period.
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass | Patients due for gastric bypass surgery | |
| Gastric banding | Patients due for gastric banding | |
| Sleeve gastrectomy | Patients due for sleeve gastrectomy | |
| Endobarrier | Patients due to undergo endoscopic Endobarrier insertion | |
| Exenatide | Patients due to be commenced on Exenatide | |
| Liraglutide | Patients due to be commenced on Liraglutide | |
| Lifestyle | Patients due to be commenced on a lifestyle intervention programme | |
| Elective surgery or endoscopy | Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Energy Intake From Baseline
The difference in total calories consumption between baseline and 12 months
Measured: Change at 12 months
Secondary outcomes (4)
Change in Appetite Ratings From Baseline
Visual Analogues difference between baseline and follow up
Measured: Change 12 months
Change in Metabolites From Baseline
Blood samples difference between baseline and follow up
Measured: Change at 12 months
Change in Hepatic Insulin Resistance From Baseline
Insulin clamps difference between baseline and follow up
Measured: Change at 1 week after intervention
Change in Macronutrient Composition From Baseline
Macronutrients difference between baseline and follow up
Measured: Change at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carel W le Roux, MRCP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724060
- Sponsor's protocol ID
- FPS
- Acronym
- FPS
- Status last verified
- Mar 2020
- First submitted
- 16 Oct 2012
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Current Treatments of Obesity on Food Preferences, Gut Hormones, Bile Acids and Hepatic Glucose Output in Humans.
- ClinicalTrials.gov ID
- NCT01724060
- Acronym / sponsor ID
- FPS / FPS
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Posted 31 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden both for patients and health systems alike. The surgical and medical treatments available for these conditions have improved significantly in the last two decades. The investigators do not however know how these treatments compare to each other and how they act in the body to cause weight loss and diabetes improvements. The studies of this experiment are complementary to each other. They aim to answer related questions and will allow us to study how these treatments work and eventually develop safer and more effective therapies for obesity and diabetes.
Detailed description
The objective of this study is to investigate the effects of obesity surgical procedures and incretin therapies on food preferences, satiety, gut hormones, bile acids and hepatic glucose output in overweight and obese patients.
As part of routine care these patients will be seen by a dietician/diabetes specialist nurse (DSN) before and after intervention. Patients will be asked to prospectively complete food diaries on three consecutive days which are representative of their usual dietary intake. The first food diary will be completed three months to two weeks pre intervention. Another four food diaries will be completed post intervention: at one, three months, 6 months and one year. Total energy intake and macronutrient composition comparisons pre and post intervention will form the basis of our analysis.
20 patients in each group will undergo more detailed measurements of food intake, hunger, satiety, gut hormones and bile acids. The research protocol will be the similar to that previously published by the Department of Metabolic Medicine, Imperial College, London. Participants will be fasted for 12 hours overnight and will attend for the study on 5 occasions. On each occasion venous blood samples will be taken and visual analogue scores will be measured over a 3 hour period using previously published methodology Samples or sample containers will be anonymised before collection but will be traceable back to the individual patients. Urine will be collected once. A qualified medical doctor will insert a venepuncture cannula into the arm of the patient and 5ml blood will be withdrawn at baseline, 15, 30, 60, 90, 120, 150 and 180 minutes following ingestion of a standard 400kcal meal as below.
Ten patients in each group (different from those taking part in the meal studies) will undergo measurements of hepatic glucose output/insulin resistance through euglycaemic hyperinsulinaemic clamps (Metabolic Study). To ensure that acute caloric restriction does not affect insulin sensitivity, patients will be on a low calorie liquid diet for 4-14 days and 3-7 days after intervention to ensure that their weight is stable throughout the study. This diet is nutritious and contains all appropriate macronutrients. Such diets are frequently used as part of pre-obesity interventions to reduce weight and risk. Patients will provide the investigators with a detailed food diary of their food consumption for this period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | – | –Patients due for gastric bypass surgery |
| Gastric banding | – | –Patients due for gastric banding |
| Sleeve gastrectomy | – | –Patients due for sleeve gastrectomy |
| Endobarrier | – | –Patients due to undergo endoscopic Endobarrier insertion |
| Exenatide | – | –Patients due to be commenced on Exenatide |
| Liraglutide | – | –Patients due to be commenced on Liraglutide |
| Lifestyle | – | –Patients due to be commenced on a lifestyle intervention programme |
| Elective surgery or endoscopy | – | –Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the community or hospital care
Key inclusion criteria (1 listed)
- Adult patients with overweight and/or obesity (BMI ≥30 Kg/m2) who are eligible for obesity treatment based on NICE guidance or that are having non bariatric surgery or endoscopy.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Energy Intake From Baseline
Time frame: Change at 12 months
The difference in total calories consumption between baseline and 12 months
4 secondary outcomes
Change in Appetite Ratings From Baseline
Time frame: Change 12 months
Change in Metabolites From Baseline
Time frame: Change at 12 months
Change in Hepatic Insulin Resistance From Baseline
Time frame: Change at 1 week after intervention
Change in Macronutrient Composition From Baseline
Time frame: Change at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carel W le Roux, MRCP PhD principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes Mellitus, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Energy Intake From Baseline (time frame: Change at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.