PrediabetesDiNA-PNCT02609243
Diabetes Nutrition Algorithm - Prediabetes
A study testing dietary consulting in people with Prediabetes and Diabetes Mellitus Type 2, run by German Institute of Human Nutrition at 2 sites in Germany.
Trial summary
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetes, Diabetes Mellitus Type 2, Obesity
- What is being tested?
- dietary consulting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2013to Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- impaired fasting glucose (IFG) fasting blood glucose 100-126 mg/dl
- and/or
- impaired glucose tolerance (IGT) 75 g OGTT 120 minutes: 140-200 mg/dl
Who cannot join
- current pregnancy or breastfeeding
- BMI > 45 kg/m²
- Diabetes mellitus Typ 1 or 2
- serious disease e.g symptomatic coronary heart disease
- serious symptomatic malignant disease (weight loss > 10% within the last 6 month)
- severe liver or kidney disease ( an increase in transaminases > 3 times than the upper limit of the standardized range, GFR < 50 ml/min/1,73m²)
Show all 16Show fewer
- systemic infection (CRP > 1 mg/dl)
- severe mental illness
- drug abuse
- treatment with steroids
- potentially incompliant subjects
- any kind of metal in or on the body: cardiac pacemakers prosthetic heart valves metal prosthesis magnetic implanted metallic parts contraceptive coil metal fragments/ grenade shrapnel fixed braces acupuncture needles insulin pump intraport etc. Field strength > 3 Tesla further tattoos, permanent make-up
- persons with limited thermosensory or heightened sensitivity to heating
- persons where cardiovascular disease cannot be ruled out by examination
- persons with heightened sensitivity to loud noise or diseases of the ear
- used closed whole body scanner: claustrophobia
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- 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: Diabetes Nutrition Algorithm - Prediabetes (Dietary Strategies in the Prevention of Diabetes Mellitus Type 2 in a High-risk Cohort)
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.
Read the detailed description
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.
The main comparison will assess differences in metabolic outcome due to low-carb or low-fat dietary intervention in short- and long-term design.
Additionally, the role of PUFA will be assessed during long-term intervention to achieve better maintenance of metabolic improvements from the first study phase.
- Conditions
- Prediabetes, Diabetes Mellitus Type 2, Obesity, NAFLD, Dyslipoproteinemia
- Being tested
- dietary consulting
- Keywords
- prediabetes, diabetes mellitus type 2, obesity, NAFLD, dyslipoproteinemia
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Obesity, Non-alcoholic Fatty Liver Disease, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary consultingBehavioural
Also called dietary intervention without supplement
dietary consulting implies specific dietary advice based on pre-interventional self-report regarding food intake; consulting focuses on nutrient content, calory intake, weight loss; with regard to randomisation consulting intensity and content varies
| Study group | Role | What they receive |
|---|---|---|
| intensive consulting, conventional diet | Active comparator | subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat ) - dietary intervention without supplement Receives: Behavioral: dietary consulting |
| conventional consulting, low-carb diet | Active comparator | subjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement Receives: Behavioral: dietary consulting |
| conventional consulting, conventional diet | Active comparator | subjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat) - dietary intervention without supplement Receives: Behavioral: dietary consulting |
| intensive consulting, low-carb diet | Active comparator | subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement Receives: Behavioral: dietary consulting |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
Measured: 3 weeks, 6 months, 1 year, 3 years
change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging
Measured: 3 weeks, 6 months, 1 year, 3 years
Secondary outcomes (3)
change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)
insulin resistance is calculated as follows:
Insulinogenic index (IGI) = (I30 - I0) / (G30 - G0) ISIest= 10000/²√ ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5))
Measured: 3 weeks, 6 months, 1 year, 3 years
change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)
insulin resistance is calculated as follows:
Insulinogenic index (IGI) = (I30 - I0) / (G30 - G0) ISIest= 10000/²√ ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5))
Measured: 3 weeks, 6 months, 1 year, 3 years
change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager
Measured: 3 weeks, 6 months, 1 year, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- German Diabetes Center
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
- Investigators
- Andreas FH Pfeiffer, Prof. Dr., Principal investigator, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609243
- Sponsor's protocol ID
- DiNA-P
- Acronym
- DiNA-P
- 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
- Diabetes Nutrition Algorithm - Prediabetes (Dietary Strategies in the Prevention of Diabetes Mellitus Type 2 in a High-risk Cohort)
- ClinicalTrials.gov ID
- NCT02609243
- Acronym / sponsor ID
- DiNA-P / DiNA-P
- Conditions
- Prediabetes, Diabetes Mellitus Type 2, Obesity, NAFLD, Dyslipoproteinemia
- Keywords
- prediabetes, diabetes mellitus type 2, obesity, NAFLD, dyslipoproteinemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- German Diabetes Center
- Study start
- Jul 2013 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Nov 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.
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.
Detailed description
Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.
The main comparison will assess differences in metabolic outcome due to low-carb or low-fat dietary intervention in short- and long-term design.
Additionally, the role of PUFA will be assessed during long-term intervention to achieve better maintenance of metabolic improvements from the first study phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| intensive consulting, conventional diet | Active comparator | Behavioral: dietary consultingsubjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat ) - dietary intervention without supplement |
| conventional consulting, low-carb diet | Active comparator | Behavioral: dietary consultingsubjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement |
| conventional consulting, conventional diet | Active comparator | Behavioral: dietary consultingsubjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat) - dietary intervention without supplement |
| intensive consulting, low-carb diet | Active comparator | Behavioral: dietary consultingsubjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- impaired fasting glucose (IFG) fasting blood glucose 100-126 mg/dl
- and/or
- impaired glucose tolerance (IGT) 75 g OGTT 120 minutes: 140-200 mg/dl
Key exclusion criteria (16 listed)
- current pregnancy or breastfeeding
- BMI > 45 kg/m²
- Diabetes mellitus Typ 1 or 2
- serious disease e.g symptomatic coronary heart disease
- serious symptomatic malignant disease (weight loss > 10% within the last 6 month)
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 consultingAlso: dietary intervention without supplementdietary consulting implies specific dietary advice based on pre-interventional self-report regarding food intake; consulting focuses on nutrient content, calory intake, weight loss; with regard to randomisation consulting intensity and content varies | Behavioural | conventional consulting, conventional diet, conventional consulting, low-carb diet, intensive consulting, conventional diet, intensive consulting, low-carb diet |
Primary outcome
change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
Time frame: 3 weeks, 6 months, 1 year, 3 years
change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging
Time frame: 3 weeks, 6 months, 1 year, 3 years
3 secondary outcomes
change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)
Time frame: 3 weeks, 6 months, 1 year, 3 years
change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)
Time frame: 3 weeks, 6 months, 1 year, 3 years
change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager
Time frame: 3 weeks, 6 months, 1 year, 3 years
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 Prediabetes
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
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. 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 in people with Prediabetes and Diabetes Mellitus Type 2, 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 16 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@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT)) (time frame: 3 weeks, 6 months, 1 year, 3 years). The study lists 2 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.