POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes

Obesity Clinical Trial

— POLYPHEM  

Official title:

POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03047668
• Other study ID #: POLYPHEM
• Status: Recruiting
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: German Institute of Human Nutrition
• Contact: Stefan Kabisch, Dr. med.
• Phone: 030 450 514 429
• Email: stefan.kabisch[@]dife.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Metabolic Syndrome
• NAFLD
• Obesity
• Type 2 Diabetes

Intervention

Dietary Supplement:
• diet with/without supplementation
diet with/without supplementation with PUFAs

Locations

Country	Name	City	State
Germany	DIfE (German Institute for Human Nutrition)	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	California Walnut Commission, German Center for Diabetes Research, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in insulin secretion (glucagon stimulation test)	change in insulin secretion (glucagon stimulation test)	49 weeks
Primary	change in hepatic fat content (MR-S)	change in hepatic fat content (MR-S)	49 weeks
Primary	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	49 weeks
Primary	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	49 weeks
Primary	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	49 weeks
Secondary	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 - IL-1; IL1beta, IL-6)	49 weeks
Secondary	change in parameters of peripheral neuropathy - vibration threshold	change in parameters of peripheral neuropathy - vibration threshold	49 weeks
Secondary	change in parameters of peripheral neuropathy - thermal sensitivity	change in parameters of peripheral neuropathy - thermal sensitivity	49 weeks
Secondary	change in parameters of peripheral neuropathy - pain thresholds	change in parameters of peripheral neuropathy - pain thresholds	49 weeks
Secondary	change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)	change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)	49 weeks
Secondary	change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)	change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)	49 weeks