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Improving Glucose and Lipid Metabolism Through Caloric Restriction Using Diet or Surgery (CRUDOS)

NCT02988011 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-10-27

No results posted yet for this study

Summary

In this explorative randomized clinical study, the investigators aim to study metabolic, cellular, and molecular changes that occur during weight loss in obese subjects with and without type 2 diabetes. Using novel "imiomics" (imaging technique using PET/MR bioinformatics) analyses to examine possible metabolic differences between energy restricted diet and gastric by-pass surgery on whole-body and tissue specific insulin sensitivity, glucose tolerance, metabolite and protein profiles, fatty acid metabolism, ectopic fat content, and gene expression in adipose tissue. This study aims to identify novel biomarkers and drug targets for type 2 diabetes as well as validate promising and established biomarkers in an interventional model for improved glucose metabolism.

Conditions

  • Type2 Diabetes
  • Weight Loss
  • Insulin Sensitivity
  • Metabolism and Nutrition Disorder
  • Metabolism Disorder, Glucose
  • Bariatric Surgery Candidate

Interventions

PROCEDURE

Gastric by-pass surgery

Gastric by-pass surgery is expected to achieve a mean weight loss of 7-8kg in 4 weeks, which is similar weight-loss achieved in the other arm (low-caloric diet) during this time period.

DIETARY_SUPPLEMENT

Low-caloric diet

Energy restricted diet with a total energy intake of 800-1200kcal/day

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Uppsala University

    lead OTHER

Principal Investigators

  • Ulf Riserus, MMed, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-28
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • Sweden

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02988011 on ClinicalTrials.gov