Status:
COMPLETED
Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes. The Hypo-energetic Study
Lead Sponsor:
Bispebjerg Hospital
Collaborating Sponsors:
University of Copenhagen
University of Aarhus
Conditions:
Diabetes Mellitus, Type 2
Overweight and Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Scientific evidence for the dietary treatment of type 2 diabetes (T2D) is insufficient, which is why the investigators aim to reform dietary recommendation to the overweight or obese patient with type...
Detailed Description
The present study will be performed as a 6-week randomized fully controlled feeding study, which will address the effect of the hypo-energetic CRHP diet compared with the hypo-energetic CD diet with t...
Eligibility Criteria
Inclusion
- Type 2 diabetes with HbA1c between 48 mmol/mol and 97 mmol/mol with or without metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors
- Overweight or obesity with BMI ≥ 25 kg/m2 and desired weight loss
- Non-smokers for \> 1 year
- Willingness to abstain from alcohol for 6 weeks
- Hemoglobin \> 7 mmol/L for men and \> 6 mmol/L for women
- Estimated glomerular filtration rate (eGFR) \> 30 mL/min/1.73 m2
Exclusion
- Critical illness as evaluated by the principal investigator
- Systemic corticosteroid treatment, e.g. prednisolone
- Reported or journalized severe food allergy or intolerance
- Reported or journalized severe gut disease e.g. Crohn's disease, Coeliac disease etc.
- Reported or journalized alcohol dependence syndrome
- Injectable diabetes medication, including insulin and GLP-1 analogues
- Sulfonylureas (SUs) and sodium-glucose cotransporter 2 (SGLT-2) inhibitors, unless discontinuation is possible, in which case a 2-month wash-out is mandatory
- Repeated fasting plasma glucose \> 13.3 mmol/L
- Urine albumin / creatinine ratio \> 300 mg/g
- Lactation, pregnancy or planning of pregnancy during the study
- Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the principal investigator
- Presently participating in other clinical trials
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03814694
Start Date
January 29 2019
End Date
December 30 2020
Last Update
January 27 2021
Active Locations (1)
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1
Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark, 2400