Type 2 DiabetesPOLYPHEMNCT03047668
POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes
A study testing diet with/without supplementation in people with Type 2 Diabetes and NAFLD, run by German Institute of Human Nutrition at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Type 2 Diabetes, NAFLD, Obesity
- What is being tested?
- diet with/without supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female subjects
- 18-79 years old
- type 2 diabetes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
DIfE (German Institute for Human Nutrition)
Berlin, 12203
Stefan Kabisch, Dr. med., 030 450 514 429, stefan.kabisch@dife.de
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes, NAFLD, Obesity, Dyslipidemia, Hypertension, Metabolic Syndrome
- Being tested
- diet with/without supplementation
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Dyslipidemias, Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet with/without supplementationDietary supplement
diet with/without supplementation with PUFAs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: diet with/without supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in insulin secretion (glucagon stimulation test)
change in insulin secretion (glucagon stimulation test)
Measured: 49 weeks
change in hepatic fat content (MR-S)
change in hepatic fat content (MR-S)
Measured: 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
Measured: 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
Measured: 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
Measured: 49 weeks
Secondary outcomes (6)
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)
Measured: 49 weeks
change in parameters of peripheral neuropathy - vibration threshold
change in parameters of peripheral neuropathy - vibration threshold
Measured: 49 weeks
change in parameters of peripheral neuropathy - thermal sensitivity
change in parameters of peripheral neuropathy - thermal sensitivity
Measured: 49 weeks
change in parameters of peripheral neuropathy - pain thresholds
change in parameters of peripheral neuropathy - pain thresholds
Measured: 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)
Measured: 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)
Measured: 49 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startMay 2013
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Diabetes Research, California Walnut Commission, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
- Investigators
- Andreas FH Pfeiffer, Prof. Dr. med., Principal investigator, DIfE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047668
- Sponsor's protocol ID
- POLYPHEM
- Acronym
- POLYPHEM
- Status last verified
- Jul 2020
- First submitted
- 21 Nov 2016
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POLY-unsaturated Fatty Acids in the Preservation of Dietary Effects on Hepatosteatosis and Energy Metabolism in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03047668
- Acronym / sponsor ID
- POLYPHEM / POLYPHEM
- Conditions
- Type 2 Diabetes, NAFLD, Obesity, Dyslipidemia, Hypertension, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- German Center for Diabetes Research, California Walnut Commission, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
- Study start
- May 2013
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low-carb with PUFA | Active comparator | Dietary Supplement: diet with/without supplementation49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), amplified with walnuts and walnut-sunflower muffins |
| low-carb without PUFA | Active comparator | Dietary Supplement: diet with/without supplementation49 weeks of hypo- to isocaloric low-carb diet (< 40 EI% carbs), without walnuts / walnut-sunflower muffins |
| low-fat with PUFA | Active comparator | Dietary Supplement: diet with/without supplementation49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), amplified with walnuts and walnut-sunflower muffins |
| low-fat without PUFA | Active comparator | Dietary Supplement: diet with/without supplementation49 weeks of hypo- to isocaloric low-fat diet (< 30 EI% fat), without walnuts / walnut-sunflower muffins |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male and female subjects
- 18-79 years old
- type 2 diabetes
Key exclusion criteria (8 listed)
- renal insufficiency
- anaemia
- immunosuppression
- previous symptomatic cancer diagnosis
- acute cardiovascular disease (stroke, coronary syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet with/without supplementationdiet with/without supplementation with PUFAs | Dietary supplement | low-carb with PUFA, low-carb without PUFA, low-fat with PUFA, low-fat without PUFA |
Primary outcome
change in insulin secretion (glucagon stimulation test)
Time frame: 49 weeks
change in insulin secretion (glucagon stimulation test)
change in hepatic fat content (MR-S)
Time frame: 49 weeks
change in hepatic fat content (MR-S)
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
Time frame: 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
Time frame: 49 weeks
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
Time frame: 49 weeks
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
6 secondary outcomes
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
Time frame: 49 weeks
change in parameters of peripheral neuropathy - vibration threshold
Time frame: 49 weeks
change in parameters of peripheral neuropathy - thermal sensitivity
Time frame: 49 weeks
change in parameters of peripheral neuropathy - pain thresholds
Time frame: 49 weeks
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (MSDD)
Time frame: 49 weeks
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN)
Time frame: 49 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas FH Pfeiffer, Prof. Dr. med. principal investigator
DIfE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet with/without supplementation in people with Type 2 Diabetes and NAFLD, run by German Institute of Human Nutrition at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Kabisch, Dr. med. (030 450 514 429, stefan.kabisch@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in insulin secretion (glucagon stimulation test) (time frame: 49 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.