Clinical trial NCT02459496: Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus
Official title: Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
NAFLD
Obesity
Dyslipoproteinaemia
Hypertension
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: German Center for Diabetes Research
name: California Walnut Company
name: Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
First posted: 2015-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in insulin secretion (glucagon stimulation test)
timeFrame: 3 weeks, 1 year
measure: change in hepatic fat content (MR-S)
timeFrame: 3 weeks, 1 year
measure: change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
timeFrame: 3 weeks, 1 year
measure: change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
timeFrame: 3 weeks, 1 year
measure: change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
timeFrame: 3 weeks, 1 year
Secondary outcomes:
measure: inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
timeFrame: 3 weeks, 1 year
measure: change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
timeFrame: 3 weeks, 1 year
measure: change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
timeFrame: 3 weeks, 1 year
Other outcomes:
Locations:
city: Bergholz-Rehbrücke
country: Germany
facility: German Institut for Human Nutrition; Department for Clinical Nutrition
state: Brandenburg
city: Berlin
country: Germany
facility: German Institute for Human Nutrition, Department for Clinical Nutrition
Study officials:
affiliation: German Institute of Human Nutrition
name: Andreas F.H. Pfeiffer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: