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

NCT ID: NCT02988011

Last Updated: 2017-10-27

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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By using omics platforms such as genomics, proteomics and metabolomics we can have large amount of information about metabolic changes at both tissue and whole body level. In parallel to this, clinical imaging modalities such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) have developed rapidly, allowing for whole-body studies of how different tissues are involved in systemic diseases. Furthermore, new hybrid systems such as integrated PET-MRI provide combined information of human morphology and function. The integration of PET with MRI reduces the radiation dose compared with PET-CT to acceptable levels for metabolic studies. To handle the large amounts of data from these examinations we are currently developing an image analysis concept, "Imiomics", that allows holistic analysis of whole-body imaging data with integration of non-imaging data. In the current study, we plan to use PET-MRI as well as imiomics methodology, together with gold standard methodology to assess insulin sensitivity and glucose tolerance in vivo. We aim to conduct a randomized study (CRUDOS study; Caloric Restriction Using Diet Or Surgery) to study glycometabolic effects before and after gastric bypass surgery and low-calorie diet in subjects at different stages of glucose tolerance (i.e. obese subjects with and without T2D).

Conditions

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

Keywords

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type 2 diabetes gastric by-pass surgery low calorie diet glucose metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastric by-pass surgery

Gastric by-pass surgery without prior low-caloric diet

Group Type ACTIVE_COMPARATOR

Gastric by-pass surgery

Intervention Type PROCEDURE

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.

Low-caloric diet

Low-caloric diet followed by gastric by-pass surgery

Group Type ACTIVE_COMPARATOR

Gastric by-pass surgery

Intervention Type PROCEDURE

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.

Low-caloric diet

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type PROCEDURE

Low-caloric diet

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Energy restricted diet

Eligibility Criteria

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Inclusion Criteria

* Age: 18-60 years
* BMI 35-45
* Sagittal abdominal diameter ≤38.5cm
* For participants with type 2 Diabetes Mellitus, a disease duration of no more than 10 years, treated with 0-3 oral antidiabetic drugs and/or with diet. HbA1C 48-80mmol/mol at baseline visit.

Exclusion Criteria

* Diabetes complications: proliferative retinopathy, maculopathy, chronic renal failure stadium 3 with an eGFR\<60, foot ulcers, symptomatic neuropathy
* Medications within 3 months: Insulin, Thiazolidinediones
* Any other condition with in the opinion of the investigator would render the participant unsuitable for inclusion in the study and /or for the patients safety
* Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements
* Pregnant or planning to be pregnant during the study.
* Known or suspected history of significant drug abuse.
* History of alcohol abuse or excessive intake of alcohol as judged by investigator.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator
* Sleep apnoea
* Any previous serious cardiovascular event, stroke, acute myocardial infarction.
* Any condition when MRI-PET is contraindicated such as, but not limited to, having a pacemaker or claustrophobia
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Ulf Risérus

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulf Riserus, MMed, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Uppsala univeristy hospital

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Magnus Sundbom, MD, PhD

Role: CONTACT

Phone: +46186114616

Email: [email protected]

Ulf Riserus, PhD

Role: CONTACT

Phone: +46186117971

Email: [email protected]

References

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Eriksson JW, Pereira MJ, Kagios C, Kvernby S, Lundstrom E, Fanni G, Lundqvist MH, Carlsson BCL, Sundbom M, Tarai S, Lubberink M, Kullberg J, Riserus U, Ahlstrom H. Short-term effects of obesity surgery versus low-energy diet on body composition and tissue-specific glucose uptake: a randomised clinical study using whole-body integrated 18F-FDG-PET/MRI. Diabetologia. 2024 Jul;67(7):1399-1412. doi: 10.1007/s00125-024-06150-3. Epub 2024 Apr 24.

Reference Type DERIVED
PMID: 38656372 (View on PubMed)

Other Identifiers

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CRUDOS AZSciLife

Identifier Type: -

Identifier Source: org_study_id