Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus

Study Overview
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Brief Summary
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Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. 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.

Detailed Description
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Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. 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.

Official Title
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Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes

Conditions
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Dyslipoproteinaemia, Type 2 Diabetes, NAFLD, Obesity, Hypertension

Intervention / Treatment
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* Behavioral: dietary consulting and advise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female subjects 18-79 years old type 2 diabetes Exclusion Criteria: renal insufficiency anaemia immunosuppression previous symptomatic cancer diagnosis acute cardiovascular disease (stroke, coronary syndrome) pregnancy and lactation severe psychiatric disorders corticoid or other immunosuppressive therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low-carb diet, followed by conventional DGE diet<br>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) | Behavioral: dietary consulting and advise<br>* first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines<br>|
| Active Comparator: very-low calory diet, followed by conventional diet<br>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 | Behavioral: dietary consulting and advise<br>* first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in insulin secretion (glucagon stimulation test) | change in insulin secretion (glucagon stimulation test) | 3 weeks, 1 year | 
| change in hepatic fat content (MR-S) | change in hepatic fat content (MR-S) | 3 weeks, 1 year | 
| change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter | change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter | 3 weeks, 1 year | 
| change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter | change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter | 3 weeks, 1 year | 
| change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter | change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter | 3 weeks, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6) | inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level) | 3 weeks, 1 year | 
| change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds | peripheral neuropathy | 3 weeks, 1 year | 
| change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD) | autonomic neuropathy | 3 weeks, 1 year |