Obesity, Type 2 Diabetes Mellitus
Conditions
Brief 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. 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 A qualified medical doctor will insert a venepuncture cannula into the arm of the patient and 5ml blood will be withdrawn at baseline, 15, 30, 60, 90, 120, 150 and 180 minutes following ingestion of a standard 400kcal meal as below.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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Energy Intake From Baseline | Change at 12 months | The difference in total calories consumption between baseline and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Appetite Ratings From Baseline | Change 12 months | Visual Analogues difference between baseline and follow up |
| Change in Metabolites From Baseline | Change at 12 months | Blood samples difference between baseline and follow up |
| Change in Hepatic Insulin Resistance From Baseline | Change at 1 week after intervention | Insulin clamps difference between baseline and follow up |
| Change in Macronutrient Composition From Baseline | Change at 12 months | Macronutrients difference between baseline and follow up |
Countries
United Kingdom
Participant flow
Pre-assignment details
There were no pre assignments requirements
Participants by arm
| Arm | Count |
|---|---|
| Gastric Bypass Patients due for gastric bypass surgery | 10 |
| Gastric Banding Patients due for gastric banding | 10 |
| Sleeve Gastrectomy Patients due for sleeve gastrectomy | 10 |
| Endobarrier Patients due to undergo endoscopic Endobarrier insertion | 10 |
| Exenatide Patients due to be commenced on Exenatide | 10 |
| Liraglutide Patients due to be commenced on Liraglutide | 10 |
| Lifestyle Patients due to be commenced on a lifestyle intervention programme | 10 |
| Elective Surgery or Endoscopy Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy | 10 |
| Total | 80 |
Baseline characteristics
| Characteristic | Gastric Banding | Sleeve Gastrectomy | Endobarrier | Exenatide | Gastric Bypass | Liraglutide | Lifestyle | Elective Surgery or Endoscopy | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 80 Participants |
| Age, Continuous | 40 year STANDARD_DEVIATION 14 | 44 year STANDARD_DEVIATION 9 | 43 year STANDARD_DEVIATION 7 | 44 year STANDARD_DEVIATION 8 | 42 year STANDARD_DEVIATION 12 | 41 year STANDARD_DEVIATION 7 | 43 year STANDARD_DEVIATION 13 | 40 year STANDARD_DEVIATION 15 | 42 year STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 80 Participants |
| Food Intake | 1490 kcal STANDARD_DEVIATION 218 | 1482 kcal STANDARD_DEVIATION 162 | 1511 kcal STANDARD_DEVIATION 197 | 1503 kcal STANDARD_DEVIATION 222 | 1505 kcal STANDARD_DEVIATION 205 | 1420 kcal STANDARD_DEVIATION 183 | 1471 kcal STANDARD_DEVIATION 193 | 1453 kcal STANDARD_DEVIATION 211 | 1503 kcal STANDARD_DEVIATION 198 |
| Region of Enrollment United Kingdom | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 80 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 4 Participants | 7 Participants | 5 Participants | 6 Participants | 3 Participants | 5 Participants | 41 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 6 Participants | 3 Participants | 5 Participants | 4 Participants | 7 Participants | 5 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Change in Energy Intake From Baseline
The difference in total calories consumption between baseline and 12 months
Time frame: Change at 12 months
Population: Patients that had specific obesity interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastric Bypass | Change in Energy Intake From Baseline | 500 kcal | Standard Deviation 55 |
| Gastric Banding | Change in Energy Intake From Baseline | 310 kcal | Standard Deviation 76 |
| Sleeve Gastrectomy | Change in Energy Intake From Baseline | 482 kcal | Standard Deviation 69 |
| Endobarrier | Change in Energy Intake From Baseline | 5 kcal | Standard Deviation 105 |
| Exenatide | Change in Energy Intake From Baseline | 27 kcal | Standard Deviation 92 |
| Liraglutide | Change in Energy Intake From Baseline | 103 kcal | Standard Deviation 74 |
| Lifestyle | Change in Energy Intake From Baseline | 11 kcal | Standard Deviation 129 |
| Elective Surgery or Endoscopy | Change in Energy Intake From Baseline | 15 kcal | Standard Deviation 114 |
Change in Appetite Ratings From Baseline
Visual Analogues difference between baseline and follow up
Time frame: Change 12 months
Change in Hepatic Insulin Resistance From Baseline
Insulin clamps difference between baseline and follow up
Time frame: Change at 1 week after intervention
Change in Macronutrient Composition From Baseline
Macronutrients difference between baseline and follow up
Time frame: Change at 12 months
Change in Metabolites From Baseline
Blood samples difference between baseline and follow up
Time frame: Change at 12 months