Type 2 Diabetes
Conditions
Keywords
diabetes, bariatric surgery, Roux-en-y gastric bypass, retinopathy, neuropathy, nephropathy
Brief summary
Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations can cause rapid and uncontrolled reductions in blood glucose. There is limited information on whether: * metabolic surgery is superior to modern medical care for glycaemic control and type 2 diabetes remission. * metabolic surgery is safe for microvascular complications of Type 2 diabetes * good glycaemic control pre surgery has any effects on the long term glycaemia and complications of type 2 diabetes. This study aims to assess: 1. whether metabolic surgery is better for diabetes control compared to medical treatment. 2. whether metabolic surgery is safe for eye, nerve and kidney complications. 3. whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.
Detailed description
This is a prospective study involving 150 patients with type 2 diabetes mellitus (T2DM) and obesity. One hundred patients will undergo gastric bypass surgery whilst 50 will be treated with best medical care. The surgical patient group will be randomised to either immediate surgery or 3 months of medical glycaemic optimisation followed by surgery (n=50 group). Intervention Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control. Group B: Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved with particular attention to the avoidance of hypoglycaemia. Group C: Obese patients with T2DM (who choose not to have surgery) will be treated with best medical care based on the ADA/EASD guidelines including anti-diabetes/obesity pharmacotherapy, access to a trained dietician and exercise programme.
Interventions
BIOLOGICALgastric bypass
Optimise glucose control within 3 months before operation
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients with T2DM and BMI above 35kg/m2 2. HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication.
Exclusion criteria
* End stage retinopathy, nephropathy or neuropathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission. | 1 year | A patient is considered to have achieved remission of T2F according to the American Diabetes Association criteria if they have fasting glucose below 6mmol/L AND HbA1c below 6% AND no medication for diabetes. Thus, a patient needs to achieve all of the three criteria (fasting glucose, HbA1C, and no medication) before being considered to be in remission. If a patient only achieves 2 of the criteria (fasting glucose and no medication) but the HbA1C is above 6% then they are not considered to be in remission. The outcome measure is calculated as the count of participants achiving the above criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A Composite of Microvascular Complications | 1 year | A composite of microvascular complications. Microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy. The outcome measure is calculated as the count of participants developing any of the microvascular events. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gastric Bypass Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control. | 21 |
| Gastric Bypass 2 Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia
gastric bypass: Optimise glucose control within 3 months before operation | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Gastric Bypass | Gastric Bypass 2 | Total |
|---|---|---|---|
| Age, Customized Age | 49 years STANDARD_DEVIATION 5 | 48.5 years STANDARD_DEVIATION 6 | 48.75 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 20 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HbA1C | 10.3 % STANDARD_DEVIATION 1.2 | 9.9 % STANDARD_DEVIATION 1.1 | 10.1 % STANDARD_DEVIATION 1.15 |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 2 / 21 | 1 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.
A patient is considered to have achieved remission of T2F according to the American Diabetes Association criteria if they have fasting glucose below 6mmol/L AND HbA1c below 6% AND no medication for diabetes. Thus, a patient needs to achieve all of the three criteria (fasting glucose, HbA1C, and no medication) before being considered to be in remission. If a patient only achieves 2 of the criteria (fasting glucose and no medication) but the HbA1C is above 6% then they are not considered to be in remission. The outcome measure is calculated as the count of participants achiving the above criteria
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gastric Bypass | Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission. | 6 Participants |
| Gastric Bypass 2 | Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission. | 6 Participants |
Secondary
A Composite of Microvascular Complications
A composite of microvascular complications. Microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy. The outcome measure is calculated as the count of participants developing any of the microvascular events.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gastric Bypass | A Composite of Microvascular Complications | 0 Participants |
| Gastric Bypass 2 | A Composite of Microvascular Complications | 0 Participants |