| Trial ID: | L0835 |
| Source ID: | NCT03047668
|
| Associated Drug: |
Polyunsaturated Fatty Acids
|
| Title: |
POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes
|
| Acronym: |
POLYPHEM
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type 2 Diabetes;NAFLD;Obesity;Dyslipidemia;Hypertension;Metabolic Syndrome
|
| Interventions: |
Dietary Supplement: diet with/without supplementation
|
| Outcome Measures: |
change in insulin secretion (glucagon stimulation test);change in hepatic fat content (MR-S);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;change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameterinflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6);change in parameters of peripheral neuropathy - vibration threshold;change in parameters of peripheral neuropathy - thermal sensitivity;change in parameters of peripheral neuropathy - pain thresholds;change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD);change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
|
| Sponsor/Collaborators: |
German Institute of Human Nutrition
|
| Gender: |
All
|
| Age: |
18 Years79 Years
|
| Phases: |
Not applicable
|
| Enrollment: |
200
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
| Start Date: |
21/11/2016
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03047668
|
