Type 2 Diabetes MellitusNUPREDMNCT03231839
Nutritional Prevention of Diabetes Mellitus Type 2
A study testing Caloric restriction, no red meat and Increased fiber intake in people with Type 2 Diabetes Mellitus and Nutritional and Metabolic Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This study investigates the influence of red meat and fibers on glucose metabolism and body fat composition in subjects at increased risk for type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Nutritional and Metabolic Diseases, Liver Fat
- What is being tested?
- Caloric restriction, no red meat and Increased fiber intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2009to 31 Jul 2016
- 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
- Individuals at a high risk for Type 2 diabetes:
- positive family history of type 2 diabetes,
- presence of metabolic syndrome,
- body mass index (BMI) > 27 kg/m2,
- diagnosis of impaired glucose tolerance (IGT)
- previous diagnosis of gestational diabetes diabetes
Who cannot join
- Main exclusion criteria
- diagnosis of type 1 or 2 diabetes mellitus
- BMI >45 kg/m²
- presence of serious illness such as cardiovascular, malignant or psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes
This study investigates the influence of red meat and fibers on glucose metabolism and body fat composition in subjects at increased risk for type 2 diabetes.
Read the detailed description
The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk factors for T2D is solid. However, few intervention studies have been performed in order to investigate the role of whole-grain intake or the consumption of red meat in glycemic control and prevention of diabetes, yielding contradicting results. Thus, in order to prove causality, further identify potential underlying mechanisms and be able to improve lifestyle modification programs, we performed a randomized, controlled intervention study over six months. The participants are individuals at increased risk for tyoe 2 diabetes. They were randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group), 2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose tolerance tests, and MRI measurements of body fat composition and iron content in the liver. In this study, we want to compare the effectiveness of reduced caloric intake only versus reduced caloric intake with an additional modification of diet composition in terms of red meat and fiber consumption.
- Conditions
- Type 2 Diabetes Mellitus, Nutritional and Metabolic Diseases, Liver Fat, Insulin Sensitivity
- Being tested
- Caloric restriction, no red meat, Increased fiber intake
- Medical subject headings
- Diabetes Mellitus, Type 2, Nutritional and Metabolic Diseases, Fatty Liver, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restrictionBehavioural
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
no red meatBehavioural
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
Increased fiber intakeBehavioural
After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Caloric restriction (control) | Placebo comparator | daily reduction of caloric intake aimed at 400 kcal/day Receives: Behavioral: Caloric restriction |
| No red meat | Active comparator | daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake Receives: Behavioral: no red meat |
| Increased fiber intake | Active comparator | daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day) Receives: Behavioral: Increased fiber intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glucose metabolism
glucose metabolism measured during the oral glucose tolerance test (OGTT)
Measured: baseline and six months
Secondary outcomes (4)
Insulin secretion
Disposition index (insulin sensitivity (Matsuda) x insulinogenic index (IGI))
Measured: baseline and six months
liver fat
measured by magnetic resonance spectroscopy
Measured: baseline and six months
liver iron content
measured by magnetic resonance imaging
Measured: baseline and six months
body composition
measured by magnetic resonance imaging
Measured: baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Feb 2009
- Primary completion30 Jun 2012
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, andreas fritsche, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231839
- Sponsor's protocol ID
- UTubingen4
- Acronym
- NUPREDM
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by ethics committee
Publications
Willmann C, Heni M, Linder K, Wagner R, Stefan N, Machann J, Schulze MB, Joost HG, Haring HU, Fritsche A. Potential effects of reduced red meat compared with increased fiber intake on glucose metabolism and liver fat content: a randomized and controlled dietary intervention study. Am J Clin Nutr. 2019 Feb 1;109(2):288-296. doi: 10.1093/ajcn/nqy307.
PubMed 30721948
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03231839
- Acronym / sponsor ID
- NUPREDM / UTubingen4
- Conditions
- Type 2 Diabetes Mellitus, Nutritional and Metabolic Diseases, Liver Fat, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 30 Jun 2012 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 27 Jul 2017 (actual)
- 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.
This study investigates the influence of red meat and fibers on glucose metabolism and body fat composition in subjects at increased risk for type 2 diabetes.
Detailed description
The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk factors for T2D is solid. However, few intervention studies have been performed in order to investigate the role of whole-grain intake or the consumption of red meat in glycemic control and prevention of diabetes, yielding contradicting results. Thus, in order to prove causality, further identify potential underlying mechanisms and be able to improve lifestyle modification programs, we performed a randomized, controlled intervention study over six months. The participants are individuals at increased risk for tyoe 2 diabetes. They were randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group), 2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose tolerance tests, and MRI measurements of body fat composition and iron content in the liver. In this study, we want to compare the effectiveness of reduced caloric intake only versus reduced caloric intake with an additional modification of diet composition in terms of red meat and fiber consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caloric restriction (control) | Placebo comparator | Behavioral: Caloric restrictiondaily reduction of caloric intake aimed at 400 kcal/day |
| No red meat | Active comparator | Behavioral: no red meatdaily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake |
| Increased fiber intake | Active comparator | Behavioral: Increased fiber intakedaily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- positive family history of type 2 diabetes,
- presence of metabolic syndrome,
- body mass index (BMI) > 27 kg/m2,
- diagnosis of impaired glucose tolerance (IGT)
- previous diagnosis of gestational diabetes diabetes
Key exclusion criteria (4 listed)
- Main exclusion criteria
- diagnosis of type 1 or 2 diabetes mellitus
- BMI >45 kg/m²
- presence of serious illness such as cardiovascular, malignant or psychiatric disease.
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 |
|---|---|---|
| Caloric restrictionAfter the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks). | Behavioural | Caloric restriction (control) |
| no red meatAfter the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks). | Behavioural | No red meat |
| Increased fiber intakeAfter the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks). | Behavioural | Increased fiber intake |
Primary outcome
change in glucose metabolism
Time frame: baseline and six months
glucose metabolism measured during the oral glucose tolerance test (OGTT)
4 secondary outcomes
Insulin secretion
Time frame: baseline and six months
liver fat
Time frame: baseline and six months
liver iron content
Time frame: baseline and six months
body composition
Time frame: baseline and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Derived from this study: PubMed 30721948Willmann C, Heni M, Linder K, Wagner R, Stefan N, Machann J, Schulze MB, Joost HG, Haring HU, Fritsche A. Potential effects of reduced red meat compared with increased fiber intake on glucose metabolism and liver fat content: a randomized and controlled dietary intervention study. Am J Clin Nutr. 2019 Feb 1;109(2):288-296. doi: 10.1093/ajcn/nqy307.
- Individual participant dataSharing planned: No. Not allowed by ethics committee
Related trials for Type 2 Diabetes Mellitus
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction, no red meat and Increased fiber intake in people with Type 2 Diabetes Mellitus and Nutritional and Metabolic Diseases, run by University Hospital Tuebingen 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 27 Jul 2017. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in glucose metabolism (time frame: baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231839, which also lists 1 linked publication.
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 27 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.