Mechanisms of Diabetes Control After Weight Loss Surgery

NCT00571220 | Completed DMC

• 2 other identifiers: DK67561 (completed)R01DK067561
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important.

Conditions

Gastric Bypass Surgery; Obesity

Keywords

gastric bypass; diabetes; obesity; diet-induced weight loss; incretin levels (GLP-1,GIP); incretin effect

Outcome Measures

Primary Outcomes (1)

• Change in incretin

  Change in incretin (gastric inhibitory peptide \[GIP\] and glucagon-like peptide-1 \[GLP-1\])

  One month

Study Arms (2)

Gastric bypass surgery

Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery

Procedure: gastric bypass surgery

Diet induced weight loss

Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age.

Other: Diet induced weight loss

Interventions

gastric bypass surgery PROCEDURE

weight loss bariatric surgery

Gastric bypass surgery

Diet induced weight loss OTHER

low calorie diet with meal replacements. weekly outpatient visits with nutritionist.

Diet induced weight loss

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Morbidly obese patients with type 2 diabetes of less than 5 years duration

You may qualify if:

• morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet.

You may not qualify if:

• any condition that would be contra-indicated for bariatric surgery (ex:unstable angina)
• diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors
• HbA1C \> 8%

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

St Luke's Roosevelt Hospital Center

New York, New York, 10025, United States

Location

Related Publications (3)

• Laferrere B, Heshka S, Wang K, Khan Y, McGinty J, Teixeira J, Hart AB, Olivan B. Incretin levels and effect are markedly enhanced 1 month after Roux-en-Y gastric bypass surgery in obese patients with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1709-16. doi: 10.2337/dc06-1549. Epub 2007 Apr 6.

  PMID: 17416796 RESULT

• Dutia R, Brakoniecki K, Bunker P, Paultre F, Homel P, Carpentier AC, McGinty J, Laferrere B. Limited recovery of beta-cell function after gastric bypass despite clinical diabetes remission. Diabetes. 2014 Apr;63(4):1214-23. doi: 10.2337/db13-1176. Epub 2013 Dec 2.

  PMID: 24296713 DERIVED

• Laferrere B, Swerdlow N, Bawa B, Arias S, Bose M, Olivan B, Teixeira J, McGinty J, Rother KI. Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):4072-6. doi: 10.1210/jc.2009-2767. Epub 2010 May 25.

  PMID: 20501690 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Blandine Laferrere, MD

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

US (1)