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

Not Applicable

• Conditions: Type 2 Diabetes; Hypertension; Metabolic Syndrome; Obesity; Dyslipidemia; NAFLD
• Interventions: Dietary Supplement: diet with/without supplementation

• Registration Number: NCT03047668
• Lead Sponsor: German Institute of Human Nutrition

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-carb without PUFA	diet with/without supplementation	49 weeks of hypo- to isocaloric low-carb diet (\< 40 EI% carbs), without walnuts / walnut-sunflower muffins
low-fat with PUFA	diet with/without supplementation	49 weeks of hypo- to isocaloric low-fat diet (\< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins
low-fat without PUFA	diet with/without supplementation	49 weeks of hypo- to isocaloric low-fat diet (\< 30 EI% fat), without walnuts / walnut-sunflower muffins
low-carb with PUFA	diet with/without supplementation	49 weeks of hypo- to isocaloric low-carb diet (\< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins

Primary Outcome Measures

Name	Time	Method
change in hepatic fat content (MR-S)	49 weeks	change in hepatic fat content (MR-S)
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter	49 weeks	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	49 weeks	change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
change in insulin secretion (glucagon stimulation test)	49 weeks	change in insulin secretion (glucagon stimulation test)
change in blood glucose profile 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

Secondary Outcome Measures

Name	Time	Method
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)	49 weeks	change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)	49 weeks	inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
change in parameters of peripheral neuropathy - pain thresholds	49 weeks	change in parameters of peripheral neuropathy - pain thresholds
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 (MSDD)
change in parameters of peripheral neuropathy - vibration threshold	49 weeks	change in parameters of peripheral neuropathy - vibration threshold
change in parameters of peripheral neuropathy - thermal sensitivity	49 weeks	change in parameters of peripheral neuropathy - thermal sensitivity

Trial Locations

Locations (1)

DIfE (German Institute for Human Nutrition); 🇩🇪 Berlin, Germany