Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study

Type 2 Diabetes Clinical Trial

— OSEBERG  

Official title:

Glycaemia, Insulin Secretion and Action in Morbidly Obese Subjects With Type 2 Diabetes After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass: A Randomised Single Centre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778738
• Other study ID #: 2012/1427b
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: November 2022

Study information

• Verified date: April 2023
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Glycaemia, insulin secretion and action in morbidly obes subjects with type 2 diabetes after sleeve gastrectomy ond Roux-en-Y gastric bypass: A randomised single centre study.

Description:

The Roux-en-Y gastric bypass operation combines restrictive and malabsorptive principles. It is the most commonly performed bariatric procedure worldwide (~ 50 %). Vertical (sleeve) gastrectomy on the other hand, is a purely restrictive procedure and has gained popularity and is now accepted as a valid procedure accounting for approximately five percent of the bariatric procedures performed worldwide. The remission rate of type 2 diabetes one to two years after bariatric surgery is approximately 70%. Some studies have indicate that the remission rate of type 2 diabetes is higher after gastric bypass than after sleeve gastrectomy. Other studies indicate a similar effect on the reduction in HbA1c. Weight reduction is comparable between gastric bypass and sleeve gastrectomy although some evidence suggets a larger weight loss following gastric bypass surgery. Larger weight loss can clearly contribute to somewhat greater improvement in glucose homeostasis after gastric bypass than after sleeve gastrectomy. Still, one might speculate that changes in gut hormones may contribute to higher remission rates of type 2 diabetes after gastric bypass than after sleeve gastrectomy. Improved β-cell function observed after gastric bypass surgery may be linked to higher postprandial levels of Glucagonlike peptide 1 as seen after gastric bypass surgery. Beta cell function has, to our knowledge, only been addressed in one previous study after sleeve gastrectomy, with the authors reporting an increased first-phase insulin secretion three days after the procedure. Although several studies have addressed changes in gastrointestinal hormones the incretin effect on insulin secretion after gastric bypass has been estimated in only a few studies. To the best of our knowledge the incretin effect on insulin secretion after sleeve gastrectomy remains unexplored.We are aware of four ongoing randomised controlled trials comparing the effect of gastric bypass and sleeve gastrectomy on several endpoints including weight and comorbidities (ClinicalTrial.gov identifiers: NCT00722995, NCT00356213, NCT00793143, and NCT00667706). However, these studies include both subjects with and with-out type 2 diabetes and are therefore not powered to detect between-group differences in HbA1c and beta-cell function in the diabetic patients. In conclusion, the effect of gastric bypass and sleeve gastrectomy on glycaemia is not fully elucidated. Moreover, the impact of altered beta-cell function post surgery needs to be explored. We hypothesise that greater improvement in beta-cell function after gastric bypass than after sleeve gastrectomy translates into better glycaemic control in subjects with type 2 diabetes one year after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2022
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Previously verified BMI =35.0 kg/m2 and current BMI =33.0 kg/m2
• HbA1c =6.5 % or use of anti-diabetic medications with HbA1c =6.1 %
• Age =18 years Exclusion criteria
• Not able to give informed consent
• Previously major abdominal surgery (appendectomy, laparoscopic cholecystectomy or gynaecological procedures not included)
• Severe endocrine-, heart-, lung-, liver- and kidney disease, cancer and other medical conditions associated with significantly increased risk of peri- and postoperative complications
• Drug or alcohol addiction
• Reduced compliance due to severe mental and psychiatric conditions
• Pregnancy
• Serum autoantibodies against glutamic acid decarboxylase (GAD) or tyrosine phosphatase (IA2)
• Regular use (a total of 3 months cumulative use in the last 12 months) or treatment the past two months with systemic corticosteroids
• Severe gastroesophageal reflux disease defined as Los Angeles classification grade > B, Barrett's oesophagus and/or hiatus hernia >5 cm
• Elevated esophageal pressure (DCI >5000 mmHg*sec*cm) and symptoms of dysphagia and/or painful swallowing.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Morbid Obesity
• Obesity, Morbid
• Type 2 Diabetes

Intervention

Procedure:
• Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy
Vertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention
• Sleeve gastrecomy
Vertical sleeve gastrectomy
• Bastric bypass
Gastric bypass surgery

Locations

Country	Name	City	State
Norway	The Morbid Obesity Center, Vestfold Hospital Trust	Tønsberg	Vestfold

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF

Country where clinical trial is conducted

Norway, 

References & Publications (8)

Borgeraas H, Hjelmesaeth J, Birkeland KI, Fatima F, Grimnes JO, Gulseth HL, Halvorsen E, Hertel JK, Hillestad TOW, Johnson LK, Karlsen TI, Kolotkin RL, Kvan NP, Lindberg M, Lorentzen J, Nordstrand N, Sandbu R, Seeberg KA, Seip B, Svanevik M, Valderhaug TG — View Citation

Fatima F, Hjelmesaeth J, Birkeland KI, Gulseth HL, Hertel JK, Svanevik M, Sandbu R, Smastuen MC, Hartmann B, Holst JJ, Hofso D. Gastrointestinal Hormones and beta-Cell Function After Gastric Bypass and Sleeve Gastrectomy: A Randomized Controlled Trial (Os — View Citation

Fatima F, Hjelmesaeth J, Hertel JK, Svanevik M, Sandbu R, Smastuen MC, Hofso D. Validation of Ad-DiaRem and ABCD Diabetes Remission Prediction Scores at 1-Year After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy in the Randomized Controlled Oseberg Tria — View Citation

Hofso D, Fatima F, Borgeraas H, Birkeland KI, Gulseth HL, Hertel JK, Johnson LK, Lindberg M, Nordstrand N, Cvancarova Smastuen M, Stefanovski D, Svanevik M, Gretland Valderhaug T, Sandbu R, Hjelmesaeth J. Gastric bypass versus sleeve gastrectomy in patien — View Citation

Hofso D, Hillestad TOW, Halvorsen E, Fatima F, Johnson LK, Lindberg M, Svanevik M, Sandbu R, Hjelmesaeth J. Bone Mineral Density and Turnover After Sleeve Gastrectomy and Gastric Bypass: A Randomized Controlled Trial (Oseberg). J Clin Endocrinol Metab. 20 — View Citation

Lorentzen J, Medhus AW, Hertel JK, Borgeraas H, Karlsen TI, Kolotkin RL, Sandbu R, Sifrim D, Svanevik M, Hofso D, Seip B, Hjelmesaeth J. Erosive Esophagitis and Symptoms of Gastroesophageal Reflux Disease in Patients with Morbid Obesity with and without T — View Citation

Lorentzen J, Medhus AW, Hofso D, Svanevik M, Seip B, Hjelmesaeth J. Sleeve Gastrectomy Confers Higher Risk of Gastroesophageal Reflux Disease Than Gastric Bypass: A Randomized Controlled Trial From the Oseberg Reflux Working Group. Gastroenterology. 2021 — View Citation

Seeberg KA, Borgeraas H, Hofso D, Smastuen MC, Kvan NP, Grimnes JO, Lindberg M, Fatima F, Seeberg LT, Sandbu R, Hjelmesaeth J, Hertel JK. Gastric Bypass Versus Sleeve Gastrectomy in Type 2 Diabetes: Effects on Hepatic Steatosis and Fibrosis : A Randomized — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of type 2 diabetes.	HbA1c below or equal to 6.0 % in the absence of glucose lowering drug therapy	One year
Primary	Beta-cell function	Disposition index calculated using glucose and insulin data obtained from a frequently sampled intravenous glucose tolerance test.	One Year
Secondary	Glycaemic control	HbA1c	Five weeks to five years
Secondary	Insulin secretion	Fasting and stimulated levels of glucose, insulin, C-peptide and proinsulin after an oral glucose load will be used for the calculation of insulin secretion.	Five weeks to five years
Secondary	Insulin sensitivity	Fasting and stimulated levels of glucose, insulin and C-peptide after an oral glucose load will be used for the calculation of insulin sensitivity.	Five weeks to five years
Secondary	Anti-diabetic medication	Use of glucose lowering agents	Five weeks to five years
Secondary	Body weight	Body weight (kg and kg/m2)	Five weeks to five years
Secondary	Body composition	Measured by DEXA and bioelectrical impedance analysis	Five weeks to five years
Secondary	Blood pressure	Resting and 24-h ambulatory systolic and diastolic blood pressure	Five weeks to five years
Secondary	Pulse wave velocity	The Sphygmocor system (Artcor, Sidney, Australia) and a single high-fidelity applanation tonometer (Millar®) will be used to measure pulse wave velocity.	Five weeks to five years
Secondary	Lipidemia	Cholesterol and triglyceride levels	Five weeks to five years
Secondary	Obstructive sleep apnoea	The ApneaLink Plus was used for the calculation of apnoeas and hypopnoeas during sleep.	Five weeks to five years
Secondary	Proteinuria	Urine protein-to-creatinine and albumin-to-creatinine ratios	Five weeks to five years
Secondary	Gastroesophageal reflux disease	Gastroesophageal reflux disease will be diagnosed using upper endoscopy, 24 hour intra-oesophageal pH monitoring and symptom scores.	One to five years
Secondary	Gastroesophageal motility disorders	High-resolution manometry	One to five years
Secondary	Fatty liver disease	MRI (Siemens Aera 1.5 T) and Chemical Shift Imaging18 will be used to quantify the fat-fraction content of the liver.	One to five years
Secondary	Gut microbiota	Microbial composition and diversity and quantification of organic acids and DNA extraction and metagenome data analysis.	One to five years
Secondary	Physical activity	Measured and self-reported physical activity	Five weeks to five years
Secondary	Energy intake and eating behaviour	Food frequency questionnaire, food tolerance questionnaire, power of food scale and binge eating scale	Five weeks to five years
Secondary	Health related quality of life	Short Form Quality of Life questionnaire (SF-36) v. 2.0	Five weeks to five years
Secondary	Obesity-related symptoms	Impact on Weight Questionnaire IWQOL-Lite and Weight-Related Symptom Measure (WRSM)	Five weeks to five years
Secondary	Psychological distress	Beck Depression Inventory	Five weeks to five years
Secondary	Bone mineral density	DEXA scan	Five weeks to five years
Secondary	Dumping syndrome	Arts' questionnaire	Five weeks to five years
Secondary	Vitamin and mineral deficiencies	Vitamin (B1, B9, B12, D) and mineral (calcium, iron) levels in blood.	Five weeks to five years