Clinical trial NCT03047668: POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes
Official title: POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
NAFLD
Obesity
Dyslipidemia
Hypertension
Metabolic Syndrome
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: German Center for Diabetes Research
name: California Walnut Commission
name: Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
First posted: 2017-02-09
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. This core comparison is dealt with in the DiNA-D study (published elsewhere).

POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors will be PUFAs and BCAAs.

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 and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients. This core comparison is dealt with in the DiNA-D study (published elsewhere).

POLYPHEM targets specific dietary approach to preserve the achieved metabolic improvements from DiNA-D phase 1. Nutritional factors for the maintenance period within DiNA-D (11 months) will be PUFAs and BCAAs, provided by walnuts and custom-made muffins containing walnuts, sunflower oil and isomaltulose.

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: 49 weeks
measure: change in hepatic fat content (MR-S)
timeFrame: 49 weeks
measure: change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
timeFrame: 49 weeks
measure: change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
timeFrame: 49 weeks
measure: change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
timeFrame: 49 weeks
Secondary outcomes:
measure: inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
timeFrame: 49 weeks
measure: change in parameters of peripheral neuropathy - vibration threshold
timeFrame: 49 weeks
measure: change in parameters of peripheral neuropathy - thermal sensitivity
timeFrame: 49 weeks
measure: change in parameters of peripheral neuropathy - pain thresholds
timeFrame: 49 weeks
measure: change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)
timeFrame: 49 weeks
measure: change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
timeFrame: 49 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: DIfE (German Institute for Human Nutrition)
Study officials:
affiliation: DIfE
name: Andreas FH Pfeiffer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: