Changes in Glucose Metabolism After Roux-en-Y Gastric Bypass

NCT01993511 | Unknown DMC

• 1 other identifier: SHJNBJ-FX10
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Besides causing weight loss Roux-en-Y gastric bypass (RYGB) has profound effect on glucose metabolism leading to remission of type 2 diabetes early after surgery. However the mechanisms for this improvement remain uncertain. The aim of this study is to investigate the changes in insulin sensitivity and beta-cell function 1 week and 3 months following RYGB using oral and intravenous test.

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in beta-cell function after RYGB.

  Beta-cell function will be assessed with both intravenous tests (acute insulin response to glucose - AIRg) and oral tests (insulinogenic index - IGI).

  1 week and 3 months.

Secondary Outcomes (1)

• Change in insulin sensitivity after RYGB.

  1 week and 3 months.

Other Outcomes (2)

• Change in glucagon and gastrointestinal hormone secretion after RYGB.

  1 week and 3 months

• Change in insulin clearance after RYGB.

  1 week and 3 months

Study Arms (3)

RYGB patients with type 2 diabetes

Preoperative oral glucose tolerance test with 2 h P-glucose \>11.1 mmol/L

RYGB patients with IGT

Preoperative oral glucose tolerance test with 2 h p-glucose \>7.8 and \<11.1 mmol/L

RYGB patients with NGT

Preoperative oral glucose tolerance test with 2 h p-Glucose \<7.8 mmol/L

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Morbid obese patients who are already enrolled for Roux-en-y gastric bypass surgery will be invited to participate (investigators do not assign patients to the surgery). 8 with type 2 diabetes, 8 with impaired glucose tolerance and 8 with normal glucose tolerance. Glucose tolerance will be assessed with an oral glucose tolerance test (OGTT) prior to surgery and prior to the other tests. Plasma glucose 120 minutes after OGTT will define glucose tolerance. Normal: \< 7,8 mM. Impaired: 7,8 - 11,1 mM. Diabetic: \>11,1 mM. Subjects are recruited from the outpatient clinic of endocrinology and gastrosurgical clinic at Hvidovre University Hospital.

You may qualify if:

• patients eligible for RYGB, Age 18-60 years, BMI 35-60 kg/m2 at time of referral to operation, blood pressure \<145/85, C-peptid\>700 pmol/l.

You may not qualify if:

• Obesity caused by medical treatment for psychiatric disease. Mental retardation. Alcohol or drug abuse. Severe cardiopulmonary disease. History of peritonitis, ventricular disease, upper gastrointestinal surgery, recurrent oesophagitis or severe complications to general anesthesia. Bad compliance. Treatment with thyroid hormones or antithyroid treatment. Treatment with anorectic medicine later than 3 months prior to surgery. Furthermore prior to surgery each patient has to loose 8 % of bodyweight to reduce the risk of operative complications.
• Before each test day all glucose lowering medication will be paused for an appropriate amount of time depending on the type of medicine.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

RECRUITING

Related Publications (2)

• Palleja A, Kashani A, Allin KH, Nielsen T, Zhang C, Li Y, Brach T, Liang S, Feng Q, Jorgensen NB, Bojsen-Moller KN, Dirksen C, Burgdorf KS, Holst JJ, Madsbad S, Wang J, Pedersen O, Hansen T, Arumugam M. Roux-en-Y gastric bypass surgery of morbidly obese patients induces swift and persistent changes of the individual gut microbiota. Genome Med. 2016 Jun 15;8(1):67. doi: 10.1186/s13073-016-0312-1.

  PMID: 27306058 DERIVED

• Martinussen C, Bojsen-Moller KN, Dirksen C, Jacobsen SH, Jorgensen NB, Kristiansen VB, Holst JJ, Madsbad S. Immediate enhancement of first-phase insulin secretion and unchanged glucose effectiveness in patients with type 2 diabetes after Roux-en-Y gastric bypass. Am J Physiol Endocrinol Metab. 2015 Mar 15;308(6):E535-44. doi: 10.1152/ajpendo.00506.2014. Epub 2015 Jan 27.

  PMID: 25628424 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

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

Study Officials

• Anna Kirstine Bojsen-Moeller, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Kirstine Bojsen-Møller, MD

CONTACT

+45 30 25 22 06; kirstine.bojsen-moeller@regionh.dk

Christoffer Martinussen, student

CONTACT

+45 22 44 55 30; hjz387@alumni.ku.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

DK (1)