Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus
NCT ID: NCT02459496
Last Updated: 2020-06-24
Study Results
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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UNKNOWN
NA
200 participants
INTERVENTIONAL
2013-09-30
2020-12-31
Brief Summary
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The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
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Detailed Description
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The researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low-carb diet, followed by conventional DGE diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day)
dietary consulting and advise
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
very-low calory diet, followed by conventional diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx. 1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines
dietary consulting and advise
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
Interventions
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dietary consulting and advise
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
Eligibility Criteria
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Inclusion Criteria
* 18-79 years old
* type 2 diabetes
Exclusion Criteria
* anaemia
* immunosuppression
* previous symptomatic cancer diagnosis
* acute cardiovascular disease (stroke, coronary syndrome)
* pregnancy and lactation
* severe psychiatric disorders
* corticoid or other immunosuppressive therapy
18 Years
79 Years
ALL
No
Sponsors
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German Center for Diabetes Research
OTHER
California Walnut Company
OTHER
Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
UNKNOWN
German Institute of Human Nutrition
OTHER
Responsible Party
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Prof. Dr. med. Andreas F. H. Pfeiffer
Director of the Department for Clinical Nutrition
Principal Investigators
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Andreas F.H. Pfeiffer, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
German Institute of Human Nutrition
Locations
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German Institut for Human Nutrition; Department for Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, Germany
German Institute for Human Nutrition, Department for Clinical Nutrition
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DiNA-D
Identifier Type: -
Identifier Source: org_study_id
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