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

Primary Purpose

Type 2 Diabetes, NAFLD, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
diet with/without supplementation
Sponsored by
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DIfE (German Institute for Human Nutrition)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

low-carb with PUFA

low-carb without PUFA

low-fat with PUFA

low-fat without PUFA

Arm Description

49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins

49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), without walnuts / walnut-sunflower muffins

49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins

49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), without walnuts / walnut-sunflower muffins

Outcomes

Primary Outcome Measures

change in insulin secretion (glucagon stimulation test)
change in insulin secretion (glucagon stimulation test)
change in hepatic fat content (MR-S)
change in hepatic fat content (MR-S)
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
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
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

Secondary Outcome Measures

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)
change in parameters of peripheral neuropathy - vibration threshold
change in parameters of peripheral neuropathy - vibration threshold
change in parameters of peripheral neuropathy - thermal sensitivity
change in parameters of peripheral neuropathy - thermal sensitivity
change in parameters of peripheral neuropathy - pain thresholds
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 (MSDD)
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)

Full Information

First Posted
November 21, 2016
Last Updated
July 21, 2020
Sponsor
German Institute of Human Nutrition
Collaborators
German Center for Diabetes Research, California Walnut Commission, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
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1. Study Identification

Unique Protocol Identification Number
NCT03047668
Brief Title
POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes
Acronym
POLYPHEM
Official Title
POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
German Center for Diabetes Research, California Walnut Commission, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, NAFLD, Obesity, Dyslipidemia, Hypertension, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low-carb with PUFA
Arm Type
Active Comparator
Arm Description
49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins
Arm Title
low-carb without PUFA
Arm Type
Active Comparator
Arm Description
49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), without walnuts / walnut-sunflower muffins
Arm Title
low-fat with PUFA
Arm Type
Active Comparator
Arm Description
49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins
Arm Title
low-fat without PUFA
Arm Type
Active Comparator
Arm Description
49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), without walnuts / walnut-sunflower muffins
Intervention Type
Dietary Supplement
Intervention Name(s)
diet with/without supplementation
Intervention Description
diet with/without supplementation with PUFAs
Primary Outcome Measure Information:
Title
change in insulin secretion (glucagon stimulation test)
Description
change in insulin secretion (glucagon stimulation test)
Time Frame
49 weeks
Title
change in hepatic fat content (MR-S)
Description
change in hepatic fat content (MR-S)
Time Frame
49 weeks
Title
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
Description
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
Time Frame
49 weeks
Title
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
Description
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
Time Frame
49 weeks
Title
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
Description
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
Time Frame
49 weeks
Secondary Outcome Measure Information:
Title
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
Description
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
Time Frame
49 weeks
Title
change in parameters of peripheral neuropathy - vibration threshold
Description
change in parameters of peripheral neuropathy - vibration threshold
Time Frame
49 weeks
Title
change in parameters of peripheral neuropathy - thermal sensitivity
Description
change in parameters of peripheral neuropathy - thermal sensitivity
Time Frame
49 weeks
Title
change in parameters of peripheral neuropathy - pain thresholds
Description
change in parameters of peripheral neuropathy - pain thresholds
Time Frame
49 weeks
Title
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)
Description
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)
Time Frame
49 weeks
Title
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
Description
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
Time Frame
49 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Kabisch, Dr. med.
Phone
030 450 514 429
Email
stefan.kabisch@dife.de
First Name & Middle Initial & Last Name or Official Title & Degree
June Inderthal
Phone
033200 88 2771
Email
june.inderthal@dife.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas FH Pfeiffer, Prof. Dr. med.
Organizational Affiliation
DIfE
Official's Role
Principal Investigator
Facility Information:
Facility Name
DIfE (German Institute for Human Nutrition)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kabisch, Dr. med.
Phone
030 450 514 429
Email
stefan.kabisch@dife.de

12. IPD Sharing Statement

Learn more about this trial

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

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