Short summary

The purpose of this randomized clinical trial is to compare metabolic-, hepatic-, cardiovascular - and intestinal microbiotic effects of a low-carbohydrate, ketogenic diet compared to a standard diet for diabetes during six months. Additionally, quality of life will be evaluated.

Rationale

Lately, attention has increasingly been directed towards low-carbohydrate diets (LCD) for patients with diabetes mellitus type 2 (DM2). There is confusion amongst researchers and health professionals whether a LCD is appropriate diet for these patients or not. Recent studies suggest that LCD is safe and effective over short-term, with significant improvements in weight and glycemic control compared to other diets. However, there is still a lack of understanding of pathophysiology and metabolic changes in reported research.  

Description of the cohort

Patients over 18 years with diagnosed Type 2 Diabetes no longer than five years and no significant comorbidity will be evaluated for enrollment. Patients must speak and understand written Danish and be motivated for change of diet. Alcohol abuse and current treatment with steatosis-inducing medication or antibiotics is an exclusion criterion. Patients will be continuously enrolled over 18 months.

Patients will be recruited from departments M and S at OUH and from the Medical Center of Soenderborg Hospital, but also through advertisement in local papers, national papers, on social media and through "www.forsoegsperson.dk". Additionally, invitations will be sent out to eligible participants in the DD2-study. Patients will be automatically screened through a survey on project website. Ads contain a QR-code linking to www.type2studie.dk.

Data and biological material

Measurement of flowmediated vasodilation, nitroglycerin-dependent vasodilation, retinalscan, DXA-scan, anthropologic measurements, blood pressure (BPTru).

Quality-of-life (SF-12)

Blood samples associated with diabetes and metabolism.

Liver biopsy, non-invasive liversudies (e.g. CAP-scan), blood samples associated with liver (metabolomics, lipidomics, etc), gut microbiota examinations.

Biobank: liver tissue, sputum, hair, feces, urine, blood (whole blood, serum, plasma)

Collaborating researchers and departments

Department of Endocrinology, Odense University Hospital

• PhD-student Eva Marie Gram-Kampmann, MD
• Professor Henning Beck-Nielsen, DMSc, PhD

Department of Medicine, Holbaek Hospital and Centre for Individualized Medicine in Arterial Disease, Odense University Hospital

• Professor Michael Hecht Olsen, PhD

Department of Medical Gastroenterology, Odense University Hospital

• Medical student Camilla Dalby Hansen
• Bjørn Stæhr Madsen, MD, PhD
• Professor Aleksander Krag, PhD

Medical Center, Soenderborg Hospital

• Frans Brandt Kristensen, MD, PhD