Effect of Roux-en-Y Gastric Bypass or Gastric Sleeve Surgery on Type 2 Diabetes

NCT02713555 | Completed

• 1 other identifier: RYGBGS2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Roux-en-Y Gastric Bypass surgery (RYGB) ameliorates type 2 diabetes within days after surgery. Studies indicate that the gastric sleeve procedure has comparable effect on type 2 diabetes, but to what extent and how is not fully elucidated. This study investigates the effect of the surgeries on incretin levels, glucose effectiveness and hepatic insulin sensitivity.

Conditions

Diabetes Mellitus, Type 2; Obesity

Outcome Measures

Primary Outcomes (2)

• Change from baseline diabetes status at 1 month after surgery

  fasting plasma glucose \< 7.0 mmol/l

  Baseline and 1 month

• Change from baseline diabetes status at 12 months after surgery

  fasting plasma glucose \< 7.0 mmol/l

  Baseline and 12 months

Secondary Outcomes (33)

• Weight loss from baseline

  Baseline to 12 months

• Weight loss from baseline

  Baseline to 1 month

• Estimates of changes in Insulin secretion from baseline

  Baseline to 1 month

• Estimates of changes in Insulin secretion from baseline

  Baseline to 12 months

• Estimates of changes in glucose effectiveness from baseline

  Baseline to 1 month

Study Arms (3)

Roux-en-Y Gastric Bypass group

EXPERIMENTAL

Morbidly obese patients with type 2 diabetes mellitus will be examined before and after the Roux-en-Y Gastric Bypass procedure

Procedure: Roux-en-Y Gastric Bypass

Gastric sleeve group

EXPERIMENTAL

Morbidly obese patient with type 2 diabetes Mellitus will be examined before and after the Gastric Sleeve procedure

Procedure: Gastric Sleeve

Method /control group

NO INTERVENTION

Healthy normal weight participants matched by age and gender to the intervention study will be examined with the same methods as the intervention groups and serve as participants in a method study and as a metabolic normal reference group.

Interventions

Roux-en-Y Gastric Bypass PROCEDURE

Roux-en-Y Gastric Bypass surgery entails the formation of a small gastric pouch and the division of the small intestine 60 cm from the duodenum. Formation of a gastrojejunal anastomosis with the distal segment and the formation of a jejuno-jejunal anastomosis 150 cm from the gastrojejunal anastomosis with the biliary segment.

Also known as: Gastric Bypass

Roux-en-Y Gastric Bypass group

Gastric Sleeve PROCEDURE

Gastric Sleeve entails a vertical division of the stomach with a stapler.

Also known as: Gastrectomy

Gastric sleeve group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 35 kg/m2
• Diabetes Mellitus, type 2

You may not qualify if:

• Diabetes Mellitus, type 1
• Chronic obstructive lung disease
• Heart failure or other cardiac disease
• Chronic inflammatory diseases
• Hepatitis or HIV
• Anemia
• Abnormal kidney or liver function
• Metabolic disease
• Prescription of prednisolone as pill or injection in the study period or 3 months prior to study start
• Alcoholism or abuse of other substances
• Pregnancy or planning to get pregnant within the study period

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator

Study Sites (1)

Hospital Unit Midt

Viborg, Region Midt, 8800, Denmark

Location

Related Publications (14)

• Madsbad S, Dirksen C, Holst JJ. Mechanisms of changes in glucose metabolism and bodyweight after bariatric surgery. Lancet Diabetes Endocrinol. 2014 Feb;2(2):152-64. doi: 10.1016/S2213-8587(13)70218-3. Epub 2014 Feb 3.

  PMID: 24622719 BACKGROUND

• Coppini LZ, Bertevello PL, Gama-Rodrigues J, Waitzberg DL. Changes in insulin sensitivity in morbidly obese patients with or without metabolic syndrome after gastric bypass. Obes Surg. 2006 Nov;16(11):1520-5. doi: 10.1381/096089206778870030.

  PMID: 17132419 BACKGROUND

• Wellford AL, Snoey ER. Emergency medicine applications of echocardiography. Emerg Med Clin North Am. 1995 Nov;13(4):831-54.

  PMID: 7588192 BACKGROUND

• Wickremesekera K, Miller G, Naotunne TD, Knowles G, Stubbs RS. Loss of insulin resistance after Roux-en-Y gastric bypass surgery: a time course study. Obes Surg. 2005 Apr;15(4):474-81. doi: 10.1381/0960892053723402.

  PMID: 15946424 BACKGROUND

• Dirksen C, Jorgensen NB, Bojsen-Moller KN, Jacobsen SH, Hansen DL, Worm D, Holst JJ, Madsbad S. Mechanisms of improved glycaemic control after Roux-en-Y gastric bypass. Diabetologia. 2012 Jul;55(7):1890-901. doi: 10.1007/s00125-012-2556-7. Epub 2012 Apr 27.

  PMID: 22538359 BACKGROUND

• Bojsen-Moller KN, Dirksen C, Jorgensen NB, Jacobsen SH, Serup AK, Albers PH, Hansen DL, Worm D, Naver L, Kristiansen VB, Wojtaszewski JF, Kiens B, Holst JJ, Richter EA, Madsbad S. Early enhancements of hepatic and later of peripheral insulin sensitivity combined with increased postprandial insulin secretion contribute to improved glycemic control after Roux-en-Y gastric bypass. Diabetes. 2014 May;63(5):1725-37. doi: 10.2337/db13-1307. Epub 2013 Nov 15.

  PMID: 24241533 BACKGROUND

• Romero F, Nicolau J, Flores L, Casamitjana R, Ibarzabal A, Lacy A, Vidal J. Comparable early changes in gastrointestinal hormones after sleeve gastrectomy and Roux-En-Y gastric bypass surgery for morbidly obese type 2 diabetic subjects. Surg Endosc. 2012 Aug;26(8):2231-9. doi: 10.1007/s00464-012-2166-y.

  PMID: 22302537 BACKGROUND

• Nielsen MF, Caumo A, Aagaard NK, Chandramouli V, Schumann WC, Landau BR, Schmitz O, Vilstrup H. Contribution of defects in glucose uptake to carbohydrate intolerance in liver cirrhosis: assessment during physiological glucose and insulin concentrations. Am J Physiol Gastrointest Liver Physiol. 2005 Jun;288(6):G1135-43. doi: 10.1152/ajpgi.00278.2004. Epub 2005 Jan 6.

  PMID: 15637182 BACKGROUND

• Dalla Man C, Caumo A, Basu R, Rizza R, Toffolo G, Cobelli C. Minimal model estimation of glucose absorption and insulin sensitivity from oral test: validation with a tracer method. Am J Physiol Endocrinol Metab. 2004 Oct;287(4):E637-43. doi: 10.1152/ajpendo.00319.2003. Epub 2004 May 11.

  PMID: 15138152 BACKGROUND

• Dalla Man C, Caumo A, Basu R, Rizza R, Toffolo G, Cobelli C. Measurement of selective effect of insulin on glucose disposal from labeled glucose oral test minimal model. Am J Physiol Endocrinol Metab. 2005 Nov;289(5):E909-14. doi: 10.1152/ajpendo.00299.2004. Epub 2005 Jun 21.

  PMID: 15972269 BACKGROUND

• Kahn SE, Prigeon RL, McCulloch DK, Boyko EJ, Bergman RN, Schwartz MW, Neifing JL, Ward WK, Beard JC, Palmer JP, et al. Quantification of the relationship between insulin sensitivity and beta-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 1993 Nov;42(11):1663-72. doi: 10.2337/diab.42.11.1663.

  PMID: 8405710 BACKGROUND

• STEELE R, WALL JS, DE BODO RC, ALTSZULER N. Measurement of size and turnover rate of body glucose pool by the isotope dilution method. Am J Physiol. 1956 Sep;187(1):15-24. doi: 10.1152/ajplegacy.1956.187.1.15. No abstract available.

  PMID: 13362583 BACKGROUND

• Visentin R, Brodersen K, Richelsen B, Moller N, Dalla Man C, Pedersen AK, Abrahamsen J, Holst JJ, Nielsen MF. Increased Insulin Secretion and Glucose Effectiveness in Obese Patients with Type 2 Diabetes following Bariatric Surgery. J Diabetes Res. 2023 Nov 14;2023:7127426. doi: 10.1155/2023/7127426. eCollection 2023.

  PMID: 38020201 DERIVED

• Brodersen K, Nielsen MF, Richelsen B, Lauritzen ES, Pahle E, Abrahamsen J, Hartmann B, Holst JJ, Moller N. Comparable Effects of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass on Basal Fuel Metabolism and Insulin Sensitivity in Individuals with Obesity and Type 2 Diabetes. J Diabetes Res. 2022 Dec 21;2022:5476454. doi: 10.1155/2022/5476454. eCollection 2022.

  PMID: 36589629 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Gastric Bypass; Gastrectomy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Katrine Brodersen, PhD student

  University of Aarhus, Hospital Unit Midt

  PRINCIPAL INVESTIGATOR

• Michael F. Nielsen, DMSc.

  University of Aarhus, Hospital Unit Midt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 18, 2016
• Study Start: July 1, 2016
• Primary Completion: February 20, 2021
• Study Completion: February 20, 2021
• Last Updated: July 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)