Postprandial Lipids MetabolismNCT01025856
Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes
A study testing Rich in MUFA diet -PA, high fiber/low glycemic index diet + pa and Rich in MUFA diet+PA in people with Postprandial Lipids Metabolism and Type 2 Diabetes, run by Federico II University.
Trial summary
The aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a diet rich in MUFA, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Postprandial Lipids Metabolism, Type 2 Diabetes
- What is being tested?
- Rich in MUFA diet -PA, high fiber/low glycemic index diet + pa and Rich in MUFA diet+PA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2011
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women
- Age 35-65 years
- BMI 27- 34 kg/m2
- HbA1c <8%
- Fasting plasma cholesterol <250 mg/dl
- Fasting plasma triglycerides <300 mg/dl
Who cannot join
- Hypolipidemic drugs
- Plasma creatinine >1.7 mg/dl transaminases > 2 norma values
- Ischemic heart disease or positive treadmill stress test
- High intensity regular physical activity
- Any disease or chronic or/and acute condition contraindicating physical activity(anaemia, and infectious, neoplastic, neurological and osteoarticular diseases).
About this study
The aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a diet rich in MUFA, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining these effects, namely changes in postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity, oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and endothelial function.
- Conditions
- Postprandial Lipids Metabolism, Type 2 Diabetes
- Being tested
- Rich in MUFA diet -PA, high fiber/low glycemic index diet + pa, Rich in MUFA diet+PA, High fibre/low glycemic index diet-PA
- Keywords
- liver fat, postprandial lipids metabolism, diet, exercise, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatty Liver, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rich in MUFA diet -PAOther
The patients will follow a rich in MUFA diet without a physical activity program.
high fiber/low glycemic index diet + paOther
patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.
Rich in MUFA diet+PAOther
Patients will follow for two months a rich in MUFA diet with a physical activity program.
High fibre/low glycemic index diet-PAOther
Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.
| Study group | Role | What they receive |
|---|---|---|
| high fibre/low glycemic index diet - P A | Active comparator | patients will follow for two months a diet high fibre/low glycemic index without physical activity program Receives: Other: High fibre/low glycemic index diet-PA |
| Rich in MUFA diet - PA | Active comparator | Patients will follow for two months a rich in MUFA diet without a physical activity program. Receives: Other: Rich in MUFA diet -PA |
| high fibre/low glycemic index diet+PA | Active comparator | Patients will follow for two months a high fibre and low glycemic index diet associated with a physical activity program. Receives: Other: high fiber/low glycemic index diet + pa |
| Rich in MUFA diet+PA | Active comparator | Patients will follow for 2 months a rich in MUFA diet with a physical activity program. Receives: Other: Rich in MUFA diet+PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
Measured: 0 and 8 weeks
postprandial lipids metabolism
Measured: 0 and 8 weeks
Secondary outcomes (3)
changes in body fat distribution
Measured: 0 and 8 weeks
oxidative stress and inflammation
Measured: 0 and 8 weeks
adipose tissue lipolytic activities
Measured: 0 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postprandial Lipids MetabolismStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025856
- Sponsor's protocol ID
- 46/09
- Status last verified
- Dec 2012
- First submitted
- 2 Dec 2009
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bozzetto L, Costabile G, Luongo D, Naviglio D, Cicala V, Piantadosi C, Patti L, Cipriano P, Annuzzi G, Rivellese AA. Reduction in liver fat by dietary MUFA in type 2 diabetes is helped by enhanced hepatic fat oxidation. Diabetologia. 2016 Dec;59(12):2697-2701. doi: 10.1007/s00125-016-4110-5. Epub 2016 Sep 20.
PubMed 27650287Bozzetto L, Annuzzi G, Costabile G, Costagliola L, Giorgini M, Alderisio A, Strazzullo A, Patti L, Cipriano P, Mangione A, Vitelli A, Vigorito C, Riccardi G, Rivellese AA. A CHO/fibre diet reduces and a MUFA diet increases postprandial lipaemia in type 2 diabetes: no supplementary effects of low-volume physical training. Acta Diabetol. 2014;51(3):385-93. doi: 10.1007/s00592-013-0522-6. Epub 2013 Oct 17.
PubMed 24132660Bozzetto L, Prinster A, Annuzzi G, Costagliola L, Mangione A, Vitelli A, Mazzarella R, Longobardo M, Mancini M, Vigorito C, Riccardi G, Rivellese AA. Liver fat is reduced by an isoenergetic MUFA diet in a controlled randomized study in type 2 diabetic patients. Diabetes Care. 2012 Jul;35(7):1429-35. doi: 10.2337/dc12-0033.
PubMed 22723581
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01025856
- Acronym / sponsor ID
- 46/09
- Conditions
- Postprandial Lipids Metabolism, Type 2 Diabetes
- Keywords
- liver fat, postprandial lipids metabolism, diet, exercise, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Dec 2009 (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.
The aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a diet rich in MUFA, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining these effects, namely changes in postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity, oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high fibre/low glycemic index diet - P A | Active comparator | Other: High fibre/low glycemic index diet-PApatients will follow for two months a diet high fibre/low glycemic index without physical activity program |
| Rich in MUFA diet - PA | Active comparator | Other: Rich in MUFA diet -PAPatients will follow for two months a rich in MUFA diet without a physical activity program. |
| high fibre/low glycemic index diet+PA | Active comparator | Other: high fiber/low glycemic index diet + paPatients will follow for two months a high fibre and low glycemic index diet associated with a physical activity program. |
| Rich in MUFA diet+PA | Active comparator | Other: Rich in MUFA diet+PAPatients will follow for 2 months a rich in MUFA diet with a physical activity program. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and postmenopausal women
- Age 35-65 years
- BMI 27- 34 kg/m2
- HbA1c <8%
- Fasting plasma cholesterol <250 mg/dl
Key exclusion criteria (5 listed)
- Hypolipidemic drugs
- Plasma creatinine >1.7 mg/dl transaminases > 2 norma values
- Ischemic heart disease or positive treadmill stress test
- High intensity regular physical activity
- Any disease or chronic or/and acute condition contraindicating physical activity(anaemia, and infectious, neoplastic, neurological and osteoarticular diseases).
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 |
|---|---|---|
| Rich in MUFA diet -PAThe patients will follow a rich in MUFA diet without a physical activity program. | Other | Rich in MUFA diet - PA |
| high fiber/low glycemic index diet + papatients will follow for two months a high fibre/ low glycemic index diet with a physical activity program. | Other | high fibre/low glycemic index diet+PA |
| Rich in MUFA diet+PAPatients will follow for two months a rich in MUFA diet with a physical activity program. | Other | Rich in MUFA diet+PA |
| High fibre/low glycemic index diet-PAPatients will follow for two months a high fibre/low glycemic index diet without a physical activity program. | Other | high fibre/low glycemic index diet - P A |
Primary outcome
Liver fat content
Time frame: 0 and 8 weeks
postprandial lipids metabolism
Time frame: 0 and 8 weeks
3 secondary outcomes
changes in body fat distribution
Time frame: 0 and 8 weeks
oxidative stress and inflammation
Time frame: 0 and 8 weeks
adipose tissue lipolytic activities
Time frame: 0 and 8 weeks
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 5 Dec 2012.
- Derived from this study: PubMed 27650287Bozzetto L, Costabile G, Luongo D, Naviglio D, Cicala V, Piantadosi C, Patti L, Cipriano P, Annuzzi G, Rivellese AA. Reduction in liver fat by dietary MUFA in type 2 diabetes is helped by enhanced hepatic fat oxidation. Diabetologia. 2016 Dec;59(12):2697-2701. doi: 10.1007/s00125-016-4110-5. Epub 2016 Sep 20.
- Derived from this study: PubMed 24132660Bozzetto L, Annuzzi G, Costabile G, Costagliola L, Giorgini M, Alderisio A, Strazzullo A, Patti L, Cipriano P, Mangione A, Vitelli A, Vigorito C, Riccardi G, Rivellese AA. A CHO/fibre diet reduces and a MUFA diet increases postprandial lipaemia in type 2 diabetes: no supplementary effects of low-volume physical training. Acta Diabetol. 2014;51(3):385-93. doi: 10.1007/s00592-013-0522-6. Epub 2013 Oct 17.
- Derived from this study: PubMed 22723581Bozzetto L, Prinster A, Annuzzi G, Costagliola L, Mangione A, Vitelli A, Mazzarella R, Longobardo M, Mancini M, Vigorito C, Riccardi G, Rivellese AA. Liver fat is reduced by an isoenergetic MUFA diet in a controlled randomized study in type 2 diabetic patients. Diabetes Care. 2012 Jul;35(7):1429-35. doi: 10.2337/dc12-0033.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rich in MUFA diet -PA, high fiber/low glycemic index diet + pa and Rich in MUFA diet+PA in people with Postprandial Lipids Metabolism and Type 2 Diabetes, run by Federico II University.
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 5 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 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Liver fat content (time frame: 0 and 8 weeks). 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?
On the ClinicalTrials.gov record for NCT01025856, which also lists 3 linked publications.
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 5 Dec 2012.