Diabetes
Conditions
Keywords
Ileal Interposition, Sleeve Gastrectomy, Type-2 Diabetes
Brief summary
Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.
Detailed description
Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body upto angle of His with a sizing bougie ranging from size 32--58 Fr.
Interventions
PROCEDUREIleal Interposition with Sleeve Gastrectomy
Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.
Sponsors
Kirloskar Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes (as defined by American Diabetes Association criteria)of more than 1 year duration * Body Mass Index 21 - 55 kg/m\^2 * Poor glycemic control (HbA1c \> 8%) despite maximal use of Oral Hypoglycemic Agents and Insulin; or good control(lower HbA1c) but requiring progressively higher drug doses. * Gives Informed Consent for the surgery * Postmeal C peptide \> 1.0 ng/mL * Age 25 - 75 years * Stable weight for more than 3 months
Exclusion criteria
* Type 1 Diabetes * Postmeal C peptide \< 1 ng/mL * Pregnancy * Significant nephropathy requiring dialysis * Coexisting systemic disease * Previous gastric or intestinal resection surgery * Obesity due to organic illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Having Remission of Type 2 Diabetes | One year | The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Not Requiring Insulin | 1 year | After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months |
| Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents | one year | Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year |
| Percentage of Participants Achieving Remission in Hypertension | 1 year | Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication |
Countries
India
Participant flow
Recruitment details
Recruitment started in Jan 2008, at Kirloskar Hospital. Recruitment completed in May 2010.
Participants by arm
| Arm | Count |
|---|---|
| Surgery Group Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Surgery Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age Continuous | 47.233 years STANDARD_DEVIATION 9.605 |
| Region of Enrollment India | 30 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Percentage of Participants Having Remission of Type 2 Diabetes
The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped
Time frame: One year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Participants Not Requiring Insulin | Percentage of Participants Having Remission of Type 2 Diabetes | 76.66 Percentage of Participants |
Secondary
Percentage of Participants Achieving Remission in Hypertension
Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Participants Not Requiring Insulin | Percentage of Participants Achieving Remission in Hypertension | 90 Percentage of Participants |
Secondary
Percentage of Participants Not Requiring Insulin
After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Participants Not Requiring Insulin | Percentage of Participants Not Requiring Insulin | 90 Percentage of Participants |
Secondary
Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents
Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Participants Not Requiring Insulin | Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents | 93 Percentage of Participants |