Gastric Bypass Surgery, Incretin Hormones Plasma Levels
Conditions
Keywords
SASJ, OAGB, GLP-1, GIP, PYY, Diabetes Mellitus
Brief summary
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 mainly, PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution.
Detailed description
The aim of this work is to compare the outcome of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with One Anastomosis Gastric Bypass (OAGB) as regards effect on levels of GLP-1 (as a primary outcome), PYY and GIP and subsequent effect on insulin resistance and Type II diabetes mellitus resolution. SASJ Group: composed of 20 patients undergoing SASJ operation. - OAGB Group: composed of 20 patients undergoing OAGB operation. Convenience sampling was used and the sample size was 40 patients. An informed consent was taken from all patients and all data are confidential, and patients will not be mentioned by name in any published paper. Patients will have the right to refuse joining the research or withdraw at any time without affecting their chance to receive the traditional therapy at any time. Regarding the Study Procedures, all patients will have preoperative workup including full history taking, general and local examination, laboratory profile including complete blood picture, liver function tests, kidney function tests, clotting profile, fasting and 2-hour postprandial blood glucose, HbA1C, serum insulin level, C-peptide (in non-insulin receiving patients) and Viral markers. Also Serum levels of GLP-1, PYY and GIP, thyroid profile (Free T3, T4 and TSH), pelviabdominal US, and upper GI endoscopy in patients with GERD or when an intra-gastric pathology is suspected. Cardiopulmonary assessment could be done if clinically indicated. Operative details - One anastomosis gastric bypass includes creation of a proximal gastric pouch and a stapled side to side gastrojejunostomy anastomosis (4.5 cm staple) is made within 200 cm from the ligament of Treitz and below the level of crow's foot. A transverse anastomosis is usually done. Single anastomosis sleeve jejunal bypass (SASJ) is a new operation for morbid obesity. The investigators will do sleeve gastrectomy using a bougie with the size of 36 Fr primarily. Then, the gastrojejunostomy anastomosis is made within 200 cm from the ligament of Treitz and the selected loop was stapled side to side (4.5 cm staple) within 6 cm or more away from the pylorus. Regarding postoperative follow up, routine follow up visits will be arranged after one month, 3 months and 6 months. Also serum levels of GLP-1, PYY and GIP will be measured 6-8 weeks post-operative. In each visit patient will have full clinical assessment including glycemic control especially HbA1c levels, fasting blood glucose levels, post prandial serum glucose levels, serum insulin levels, C peptide levels (in non-insulin receiving patients), weight loss rate and total weight loss percentage calculated with nutritional parameters like serum calcium, iron, albumin, vitamin D and PTH will be assessed once after 6 months.
Interventions
Single anastomosis sleeve jejunal bypass (SASJ) is a new operation for morbid obesity. The investigator will do sleeve gastrectomy using a bougie with the size of 36 Fr primarily. Then, the gastrojejunostomy anastomosis is made within 200 cm from the ligament of Treitz and the selected loop was stapled side to side (4.5 cm staple) within 6 cm or more away from the pylorus.
PROCEDUREOne anastomosis gastric bypass
One anastomosis gastric bypass includes creation of a proximal gastric pouch and a stapled side to side gastrojejunostomy anastomosis (4.5 cm staple) is made within 200 cm from the ligament of Treitz and below the level of crow's foot.
Sponsors
Ain Shams University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A Prospective Partially Randomized Patient Preference Comparative Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients age from 18 to 60 years old. * Both sexes. * Patients with BMI ≥ 35 with Type II diabetes mellitus.
Exclusion criteria
* Patients underwent previous Bariatric surgeries. * Patients with severe systemic disease (ASA 4), such as congestive heart failure - unstable angina - recent stroke or myocardial infarction less than 3 months ago. * Patients who refuse to participate in the study. * Patients with psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the change in measurable plasma levels of GLP-1 after the assigned operation. GLP-1 levels will be measured using (pmol/L) unit. | Serum levels of GLP-1 will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative. | Plasma levels of Incretin GLP-1 are measured before and after the assigned operation using ELISA kits.GLP-1 levels will be measured using (pmol/L) unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the change in plasma levels GIP after the assigned operation. Serum levels will be measured using (pmol/L) unit. | 6-8 weeks post operative | Plasma levels of Incretin GIP are measured before and after the assigned operation using ELISA kits.GIP levels will be measured using (pmol/L) unit. Serum levels of GIP will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative. |
| Determine the change in plasma levels Peptide-YY (PYY) after the assigned operation. Serum levels will be measured using (pmol/L) unit. | 6-8 weeks post operative | Plasma levels of Incretin PYY are measured before and after the assigned operation using ELISA kits. Serum levels will be measured using (pmol/L) unit. Serum levels of PYY will be measured 6-8 weeks post-operative, with routine follow up visits planned for 1 year post-operative. |
| Total weight loss percentage | 6-8 weeks post operative | Measurement of total weight loss percentage (TWL%) 6-8 weeks post operative. |
| Glycemic control (Fasting) | 6-8 weeks post operative | Full clinical assessment including fasting blood glucose levels in mg/dL |
| Glycemic control (Postprandial) | 6-8 weeks post operative | Full clinical assessment including 2 hour post-prandial blood glucose levels in mg/dL. |
| Type II DM resolution | 6-8 weeks post operative | Blood HbA1c levels in percentage |
Countries
Egypt
Contacts
STUDY_DIRECTORMohey Eldin R ElBanna, Professor of General Surgery
Ain Shams University
Outcome results
None listed