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Trial record 42 of 7520 for:    Type 2 Diabetes

Mitigation of Type 2 Diabetes by Partial Ileal Bypass

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ClinicalTrials.gov Identifier: NCT02493374
Recruitment Status : Recruiting
First Posted : July 9, 2015
Last Update Posted : December 7, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a study of people with type 2 diabetes and high cholesterol between age 18 and 65. This study is trying to figure out if a partial bypass of the small intestine can reverse type 2 diabetes for people who require cholesterol lowering and who cannot tolerate the statin drugs.

Condition or disease
Type 2 Diabetes

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mitigation of Type 2 Diabetes in Hypercholesterolemic Patients Undergoing a Partial Ileal Bypass
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Mitigation of Type 2 Diabetes [ Time Frame: 3 years ]
    Blood draws only


Biospecimen Retention:   Samples Without DNA
blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals in need of lipid modification but are intolerant of statin drugs who are referred for a partial ileal bypass (PIB) operation, still the most efficacious means to treat hyperlipidemia. In the subgroup of these patients who also have type 2 diabetes, with a functioning pancreas, we hope to perform a pilot study on the effect of PIB on type 2 diabetes.

Study blood tests:

- Pre-PIB and at 6 month and 12 months postop fasting blood samples for glucose, hemoglobin A1c, insulin, C-peptide, GLP-1, ghrelin, and glucagon; then after oral glucose meal testing for determination of glucose, GLP-1, and ghrelin at 30, 60, 90, and 120 minutes.

Criteria

Inclusion Criteria:

  • Hyperlipidemia patients referred for partial ileal bypass, who also have type 2 diabetes.

Exclusion Criteria:

  • Preoperative C-peptide indicative of non-functioning islet cells.
Contacts and Locations

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): NCT02493374


Contacts
Contact: Henry Buchwald, MD, PhD 612-625-5401 buchw001@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: P. Nordberg, MHA, PhD    612-672-6737    mnordbe2@fairview.org   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Weill Medical College of Cornell University
Brigham and Women's Hospital
Investigators
Principal Investigator: Henry Buchwald, MD, PhD University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02493374     History of Changes
Other Study ID Numbers: 1504M69662
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases