- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02988011
Improving Glucose and Lipid Metabolism Through Caloric Restriction Using Diet or Surgery (CRUDOS) (CRUDOS)
25. oktober 2017 opdateret af: Ulf Risérus, Uppsala University
Influence of Weight Loss by Diet and Surgery on Metabolomic Profile, Body Composition, and Tissue Specific Glucose Uptake: Insights in Type 2 Diabetes Regression (CRUDOS Study)
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Uppsala, Sverige, 75185
- Rekruttering
- Uppsala Univeristy Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Gastric by-pass surgery
Gastric by-pass surgery without prior low-caloric diet
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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.
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Aktiv komparator: Low-caloric diet
Low-caloric diet followed by gastric by-pass surgery
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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.
Energy restricted diet with a total energy intake of 800-1200kcal/day
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in tissue specific glucose uptake measured by euglycemic clamp in PET/MR scanner
Tidsramme: 4 weeks
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Tissue specific assessment of glucose metabolism (18FDG uptake) using in-scanner (integrated PET-MR) insulin clamps.
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4 weeks
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Metabolite concentrations in plasma
Tidsramme: 4 weeks
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Plasma metabolite concentrations (metabolomics) are assessed by liquid chromatography-mass spectrometry
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4 weeks
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Gene expression in adipose tissue
Tidsramme: 4 weeks
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Change in gene expression is assessed by microarray (untargeted) messenger ribonucleic acid (mRNA) analyses
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4 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Lipoprotein changes in plasma assessed by routine clinical chemistry
Tidsramme: 4 weeks
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4 weeks
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Plasma adipokines (e.g. adiponectin) assessed by elisa
Tidsramme: 4 weeks
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4 weeks
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Fatty acid composition in plasma assessed by gas chromatography
Tidsramme: 4 weeks
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4 weeks
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Changes in plasma protein profile (proteomics) assessed by immunohistochemistry
Tidsramme: 4 weeks
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4 weeks
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Epigenetic changes assessed as DNA methylation
Tidsramme: 4 weeks
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4 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ulf Riserus, MMed, PhD, Uppsala University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. februar 2016
Primær færdiggørelse (Forventet)
1. juni 2020
Studieafslutning (Forventet)
1. december 2020
Datoer for studieregistrering
Først indsendt
1. december 2016
Først indsendt, der opfyldte QC-kriterier
6. december 2016
Først opslået (Skøn)
9. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRUDOS AZSciLife
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Most of the data is planned to be shared after the study has ended, the date for when this will occur however needs to be decided.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Gastric by-pass surgery
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Max Institute of Minimally Access, Metabolic &...Aktiv, ikke rekrutterendeType 2 diabetes mellitusIndien