Type 2 DiabetesDiNA-DNCT02459496
Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus
A study testing dietary consulting and advise in people with Type 2 Diabetes and NAFLD, run by German Institute of Human Nutrition at 2 sites 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?
- dietary consulting and advise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 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
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Not yet recruiting
German Institut for Human Nutrition; Department for Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, 14458
Margrit Kemper, Dr. med., 033200 88 2775, margrit.kemper@dife.de
Silke Hornemann, 033200 88 2779, silke.hornemann@dife.de
- Recruiting
German Institute for Human Nutrition, Department for Clinical Nutrition
Berlin, 12203
Stefan Kabisch, Dr. med., 030 450 514 ext. 429, stefan.kabisch@charite.de
Ulrike Kaiser, M.sc., 030 450 514 ext. 428, ulrike.kaiser@charite.de
About this study
Official title: Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
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.
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 diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.
- Conditions
- Type 2 Diabetes, NAFLD, Obesity, Dyslipoproteinaemia, Hypertension
- Being tested
- dietary consulting and advise
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary consulting and adviseBehavioural
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
| Study group | Role | What they receive |
|---|---|---|
| low-carb diet, followed by conventional DGE diet | Active comparator | subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day) Receives: Behavioral: dietary consulting and advise |
| very-low calory diet, followed by conventional diet | Active comparator | subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx. 1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines Receives: Behavioral: dietary consulting and advise |
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: 3 weeks, 1 year
change in hepatic fat content (MR-S)
change in hepatic fat content (MR-S)
Measured: 3 weeks, 1 year
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: 3 weeks, 1 year
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: 3 weeks, 1 year
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: 3 weeks, 1 year
Secondary outcomes (3)
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)
Measured: 3 weeks, 1 year
change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
peripheral neuropathy
Measured: 3 weeks, 1 year
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
autonomic neuropathy
Measured: 3 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startSep 2013
- Primary completionDec 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 Company, 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 F.H. Pfeiffer, Prof. Dr. med., Principal investigator, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459496
- Sponsor's protocol ID
- DiNA-D
- Acronym
- DiNA-D
- Status last verified
- Jun 2020
- First submitted
- 23 Mar 2015
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02459496
- Acronym / sponsor ID
- DiNA-D / DiNA-D
- Conditions
- Type 2 Diabetes, NAFLD, Obesity, Dyslipoproteinaemia, Hypertension
- 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 Company, Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Jun 2015 (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.
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 diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-carb diet, followed by conventional DGE diet | Active comparator | Behavioral: dietary consulting and advisesubjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day) |
| very-low calory diet, followed by conventional diet | Active comparator | Behavioral: dietary consulting and advisesubjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx. 1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines |
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 |
|---|---|---|
| dietary consulting and advisefirst phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines | Behavioural | low-carb diet, followed by conventional DGE diet, very-low calory diet, followed by conventional diet |
Primary outcome
change in insulin secretion (glucagon stimulation test)
Time frame: 3 weeks, 1 year
change in insulin secretion (glucagon stimulation test)
change in hepatic fat content (MR-S)
Time frame: 3 weeks, 1 year
change in hepatic fat content (MR-S)
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
Time frame: 3 weeks, 1 year
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: 3 weeks, 1 year
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: 3 weeks, 1 year
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
3 secondary outcomes
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
Time frame: 3 weeks, 1 year
change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
Time frame: 3 weeks, 1 year
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
Time frame: 3 weeks, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 F.H. Pfeiffer, Prof. Dr. med. principal investigator
German Institute of Human Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary consulting and advise in people with Type 2 Diabetes and NAFLD, run by German Institute of Human Nutrition at 2 sites 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 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 ext. 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: 3 weeks, 1 year). 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 24 Jun 2020.