Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus

Not Applicable

• Conditions: NAFLD; Type 2 Diabetes; Obesity; Dyslipoproteinaemia; Hypertension
• Interventions: Behavioral: dietary consulting and advise

• Registration Number: NCT02459496
• Lead Sponsor: German Institute of Human Nutrition

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-02
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-carb diet, followed by conventional DGE diet	dietary consulting and advise	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)
very-low calory diet, followed by conventional diet	dietary consulting and advise	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

German Institut for Human Nutrition; Department for Clinical Nutrition; 🇩🇪 Bergholz-Rehbrücke, Brandenburg, Germany

German Institute for Human Nutrition, Department for Clinical Nutrition; 🇩🇪 Berlin, Germany