Diabetes MellitusNCT02442024
Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients
A study testing Modified Diet and Standard Diet in people with Diabetes Mellitus, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The investigators aimed at evaluating the metabolic effects of the inversion of the typical Italian sequence of food ingestion at the main meals in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Modified Diet and Standard Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Dec 2015
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Well-controlled type 2 diabetes
- HbA1c 48-58 mmol/mol (6.5-7.5%)
- Treatment with metformin or diet only
- BMI: < 35 kg/m^2
Who cannot join
- Autoimmune diseases, neoplasia, heart, kidney, liver or respiratory failure
- Pregnancy
- Bariatric surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56127
Andrea Natali, Professor, 050992814, andrea.natali@med.unipi.it
Andrea Natali, Professor
About this study
The investigators aimed at evaluating the metabolic effects of the inversion of the typical Italian sequence of food ingestion at the main meals in type 2 diabetic patients.
Read the detailed description
An intervention group follows a modified diet over a period of two months in which the ingestion of protein and lipid happens before that of carbohydrates. A control group follows a standardized diet in which the ingestion of carbohydrates happens before that of protein and lipid. Both diets contain a reduced intake of high-glycemic index meals, saturated fatty acids, trans fatty acids and alcohol.
On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) we measure clinical and metabolic parameters (weight, waist and hip circumferences, glucose, glycated hemoglobin, fructosamine, lipid profile) to compare the effects of the two diets.
- Conditions
- Diabetes Mellitus
- Being tested
- Modified Diet, Standard Diet
- Keywords
- diabetes mellitus, diet, nutrient sensing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified DietBehavioural
Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates.
Standard DietBehavioural
Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates.
| Study group | Role | What they receive |
|---|---|---|
| Modified diet | Experimental | This group will follow a modified diet over a period of two months. Receives: Behavioral: Modified Diet |
| Standard diet | Active comparator | This group will follow a standardized diet over a period of two months. Receives: Behavioral: Standard Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline fructosamine after 1 and 2 months of diet
Fructosamine will be measured.
Measured: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Secondary outcomes (5)
Change from baseline fasting plasma glucose after 1 and 2 months of diet
Fasting plasma glucose will be measured.
Measured: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Change from baseline glycated hemoglobin after 1 and 2 months of diet
Glycated hemoglobin will be measured.
Measured: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Change from baseline weight after 1 and 2 months of diet adipose tissue location
Waist circumference and hip circumference will be measured.
Measured: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Change from baseline adipose tissue location after 1 and 2 months of diet
Weight, waist circumference and hip circumference will be measured.
Measured: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Change from baseline lipid profile after 1 and 2 months of diet
Lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) will be measured.
Measured: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natali, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Andrea Natali, Professor, Study chair, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442024
- Sponsor's protocol ID
- CEPPO
- Status last verified
- May 2015
- First submitted
- 7 May 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02442024
- Acronym / sponsor ID
- CEPPO
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, diet, nutrient sensing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 May 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.
The investigators aimed at evaluating the metabolic effects of the inversion of the typical Italian sequence of food ingestion at the main meals in type 2 diabetic patients.
Detailed description
An intervention group follows a modified diet over a period of two months in which the ingestion of protein and lipid happens before that of carbohydrates. A control group follows a standardized diet in which the ingestion of carbohydrates happens before that of protein and lipid. Both diets contain a reduced intake of high-glycemic index meals, saturated fatty acids, trans fatty acids and alcohol.
On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) we measure clinical and metabolic parameters (weight, waist and hip circumferences, glucose, glycated hemoglobin, fructosamine, lipid profile) to compare the effects of the two diets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified diet | Experimental | Behavioral: Modified DietThis group will follow a modified diet over a period of two months. |
| Standard diet | Active comparator | Behavioral: Standard DietThis group will follow a standardized diet over a period of two months. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Well-controlled type 2 diabetes
- HbA1c 48-58 mmol/mol (6.5-7.5%)
- Treatment with metformin or diet only
- BMI: < 35 kg/m^2
Key exclusion criteria (3 listed)
- Autoimmune diseases, neoplasia, heart, kidney, liver or respiratory failure
- Pregnancy
- Bariatric surgery
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 |
|---|---|---|
| Modified DietTwo months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates. | Behavioural | Modified diet |
| Standard DietTwo months of a diet in which the ingestion of protein and lipid follows that of carbohydrates. | Behavioural | Standard diet |
Primary outcome
Change from baseline fructosamine after 1 and 2 months of diet
Time frame: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Fructosamine will be measured.
5 secondary outcomes
Change from baseline fasting plasma glucose after 1 and 2 months of diet
Time frame: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Change from baseline glycated hemoglobin after 1 and 2 months of diet
Time frame: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Change from baseline weight after 1 and 2 months of diet adipose tissue location
Time frame: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Change from baseline adipose tissue location after 1 and 2 months of diet
Time frame: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Change from baseline lipid profile after 1 and 2 months of diet
Time frame: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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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.
Andrea Natali, Professor study chair
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Diet and Standard Diet in people with Diabetes Mellitus, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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 4 inclusion and 3 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 13 May 2015. 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 Italy. 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 Andrea Natali, Professor (+39050992814, andrea.natali@med.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline fructosamine after 1 and 2 months of diet (time frame: On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet)). 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 13 May 2015.