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

NCT03047668 | Unknown

• 1 other identifier: POLYPHEM
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; NAFLD; Obesity; Dyslipidemia; Hypertension; Metabolic Syndrome

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (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

  49 weeks

• change in parameters of peripheral neuropathy - thermal sensitivity

  49 weeks

• change in parameters of peripheral neuropathy - pain thresholds

  49 weeks

• change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)

  49 weeks

Study Arms (4)

low-carb with PUFA

ACTIVE COMPARATOR

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

low-carb without PUFA

ACTIVE COMPARATOR

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

Dietary Supplement: diet with/without supplementation

low-fat with PUFA

ACTIVE COMPARATOR

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

low-fat without PUFA

ACTIVE COMPARATOR

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

Dietary Supplement: diet with/without supplementation

Interventions

diet with/without supplementation DIETARY_SUPPLEMENT

diet with/without supplementation with PUFAs

low-carb with PUFA; low-carb without PUFA; low-fat with PUFA; low-fat without PUFA

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female subjects
• years old
• type 2 diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• German Center for Diabetes Research: collaborator
• California Walnut Commission: collaborator
• Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV): collaborator

Study Sites (1)

DIfE (German Institute for Human Nutrition)

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Obesity; Dyslipidemias; Hypertension; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Andreas FH Pfeiffer, Prof. Dr. med.

  DIfE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Kabisch, Dr. med.

CONTACT

030 450 514 429; stefan.kabisch@dife.de

June Inderthal

CONTACT

033200 88 2771; june.inderthal@dife.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: February 9, 2017
• Study Start: May 1, 2013
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

DE (1)