MedDataX Logo

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

NCT ID: NCT01993511

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RYGB patients with type 2 diabetes

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

No interventions assigned to this group

RYGB patients with IGT

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

No interventions assigned to this group

RYGB patients with NGT

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anna Kirstine Bojsen-Moeller

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna Kirstine Bojsen-Moeller, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna Kirstine Bojsen-Møller, MD

Role: CONTACT

Phone: +45 30 25 22 06

Email: [email protected]

Christoffer Martinussen, student

Role: CONTACT

Phone: +45 22 44 55 30

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anna Kirstine Bojsen-Møller, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27306058 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25628424 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHJNBJ-FX10

Identifier Type: -

Identifier Source: org_study_id