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

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ClinicalTrials.gov Identifier: NCT01993511
Recruitment Status : Unknown
Verified November 2013 by Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital

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.

Condition or disease
Type 2 Diabetes Obesity

Detailed Description:
Investigators plan to study 24 obese patients already enrolled for Roux-en-y gastric bypass surgery (RYGB). 8 with type 2 diabetes (DM2), 8 with impaired glucose tolerance (IGT) and 8 with normal glucose tolerance (NGT) before, within the first week and 3 month after RYGB using a liquid mixed meal test (MMT) and an insulin modified frequently sampled intravenous glucose tolerance test (IM-FSIGT). Furthermore, an oral glucose tolerance test (OGTT) will be performed before and after 3 months. Blood will be sampled in fasting and during the tests measuring plasma glucose, insulin and C-peptid (OGTT, MMT and IM-FSIGT) and GLP-1, glucagon, GIP and GLP-2 (MMT). Beta-cell function will be assessed from the MMT (insulinogenic index - IGI), OGTT (IGI) and the IM-FSIGT (Acute insulin response, AIR) in order to examine whether changes in beta-cell function after RYGB depend on an oral stimulus. Insulin sensitivity will be assessed in fasting (HOMA-IR), during the IM-FSIGT (minimal model: Si) and from MMT/OGTT (Matsuda index). Insulin clearance/hepatic extraction of insulin will be assessed in fasting and during the intravenous and oral test.

Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Glucose Metabolism After Roux-en-Y Gastric Bypass
Study Start Date : June 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Change in beta-cell function after RYGB. [ Time Frame: 1 week and 3 months. ]
    Beta-cell function will be assessed with both intravenous tests (acute insulin response to glucose - AIRg) and oral tests (insulinogenic index - IGI).


Secondary Outcome Measures :
  1. Change in insulin sensitivity after RYGB. [ Time Frame: 1 week and 3 months. ]
    Insulin sensitivity will be assessed in fasting and by intravenous tests (sensitivity index - Si) and oral tests (Matsuda index).


Other Outcome Measures:
  1. Change in glucagon and gastrointestinal hormone secretion after RYGB. [ Time Frame: 1 week and 3 months ]
  2. Change in insulin clearance after RYGB. [ Time Frame: 1 week and 3 months ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993511


Contacts
Contact: Anna Kirstine Bojsen-Møller, MD +45 30 25 22 06 kirstine.bojsen-moeller@regionh.dk
Contact: Christoffer Martinussen, student +45 22 44 55 30 hjz387@alumni.ku.dk

Locations
Denmark
Hvidovre University Hospital Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Anna Kirstine Bojsen-Møller, MD    +45 30 25 22 06    kirstine.bojsen-moeller@regionh.dk   
Principal Investigator: Anna Kirstine Bojsen-Møller, MD         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Anna Kirstine Bojsen-Moeller, MD Hvidovre University Hospital