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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Obesity; Metabolic Syndrome; Type 2 Diabetes; Dyslipidemia; NAFLD
• Intervention / Treatment: Dietary supplement: diet with/without supplementation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: June Inderthal; Phone Number: 033200 88 2771; Email: june.inderthal@dife.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • DIfE (German Institute for Human Nutrition)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: low-carb with PUFA; 49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins	Dietary supplement: diet with/without supplementation; diet with/without supplementation with PUFAs
ACTIVE_COMPARATOR: low-carb without PUFA; 49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), without walnuts / walnut-sunflower muffins	Dietary supplement: diet with/without supplementation; diet with/without supplementation with PUFAs
ACTIVE_COMPARATOR: low-fat with PUFA; 49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins	Dietary supplement: diet with/without supplementation; diet with/without supplementation with PUFAs
ACTIVE_COMPARATOR: low-fat without PUFA; 49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), without walnuts / walnut-sunflower muffins	Dietary supplement: diet with/without supplementation; diet with/without supplementation with PUFAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in insulin secretion (glucagon stimulation test)	change in insulin secretion (glucagon stimulation test)	49 weeks
change in hepatic fat content (MR-S)	change in hepatic fat content (MR-S)	49 weeks
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change in parameters of peripheral neuropathy - vibration threshold	change in parameters of peripheral neuropathy - vibration threshold	49 weeks
change in parameters of peripheral neuropathy - thermal sensitivity	change in parameters of peripheral neuropathy - thermal sensitivity	49 weeks
change in parameters of peripheral neuropathy - pain thresholds	change in parameters of peripheral neuropathy - pain thresholds	49 weeks
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
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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: California Walnut Commission; German Center for Diabetes Research; Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
• Investigators: Principal Investigator: Andreas FH Pfeiffer, Prof. Dr. med., DIfE

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (ESTIMATE): February 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Dyslipidemias
• Other Study ID Numbers: POLYPHEM