Type 2 DiabetesCRESO2NCT01930136
Effects of Caloric Restriction in Obesity and Type 2 Diabetes
A study testing Calorie restriction (25%) and Ad libitum health diet in people with Type 2 Diabetes and Obesity, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
The study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Calorie restriction (25%) and Ad libitum health diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to 5 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >40 years;
- Type 2 diabetes (ADA criteria);
- UAE <300 mg/24h;
- Body mass index (BMI)>27kg/m2;
- Serum creatinine < 1.2 mg/dL;
- No major changes in calorie, protein and sodium intake in the last 6 mos;
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- No major changes in concomitant treatments with blood pressure, glucose or lipid lowering agents since 6 and 3 months respectively;
- Patients legally able to give written informed consent to the trial (signed and dated by the patient);
- Written informed consent.
Who cannot join
- Concomitant non-diabetic renal disease or ischemic kidney disease;
- Primary or immune-mediated renal disease;
- Urinary tract obstruction or infection;
- Treatment with steroids and/or non-steroid anti-inflammatory agents;
- Treatment with thiazide or loop diuretics that, on the basis of the Investigator's judgment, might sustain hypovolemia and/or sodium depletion (with secondary kidney hypoperfusion/hypofiltration);
- Hearth failure and/or hemodynamically significant left ventricular systolic dysfunction, cirrhosis, uncontrolled hyperglycemia resulting in glycosuria, hyper/hyponatremia of any cause;
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- Previous surgical procedures for weight loss;
- Previous episodes of depression, or suicide attempts;
- Chronic abuse of alcohol and drugs;
- Pregnancy, ineffective contraception or peri-menopausal age;
- Cancer or any chronic disease that might affect the completion of the study;
- Chronic obstructive pulmonary disease (COPD) in treatment with positive airway pressure;
- Unwillingness or inability to adhere to CR intervention over the entire 24-months intervention period;
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
- Evidence of an uncooperative attitude;
- Any evidence that patient will not be able to complete the trial follow-up;
- Inability to fully understand the potential risks and benefits of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of Caloric Restriction on Metabolic, Renal End Retinal Health in Subjectsaffected by Obesityand Type 2 Diabetes
The study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral obesity, insulin resistance, dyslipidemia, hypertension and inflammation.
The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on subjects at risk of nephropathy. Secondary aims are to better understand the relationship between CR and the following aspects: renal disease and its associated metabolic abnormalities, retinopathy and cardiovascular complications, quality of life and treatment cost.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Calorie restriction (25%), Ad libitum health diet
- Keywords
- Calorie restriction, Type 2 diabetes, Obesity, Diabetic nephropathy prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restriction (25%)Behavioural
Ad libitum health dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Calorie restriction (25%) | Experimental | CR will correspond to a reduction of 25% from the total daily calorie expenditure calculated as Total Daily Energy Expenditure (TDEE) (kcal/d) using the formula from the validated Seven-Day Physical Activity Recall (PAR) Questionnaire (RMR x activity levels). Receives: Behavioral: Calorie restriction (25%) |
| Ad libitum health diet | Active comparator | Not described Receives: Behavioral: Ad libitum health diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in glomerular filtration rate (GFR) at month 6 versus baseline and the rate of GFR decline from month 6 to study end
Measured: At baseline, 6, 12 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startMay 2013
- Primary completion5 May 2022
- Study completion5 May 2022
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Superiore di Sanità
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930136
- Sponsor's protocol ID
- CRESO 2
- Acronym
- CRESO2
- Status last verified
- May 2022
- First submitted
- 23 Aug 2013
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruggenenti P, Cortinovis M, Trillini M, Parvanova A, Abbate M, Satriano C, Salvetti F, Bossi AC, Trevisan R, Perna A, Peracchi T, Rubis N, Diadei O, Martinetti D, Gaspari F, Fontana L, Remuzzi G; CRESO 2 Study; Organization. Long-term kidney and systemic effects of calorie restriction in overweight or obese type 2 diabetic patients (C.Re.S.O. 2 randomized controlled trial). Diabetes Res Clin Pract. 2022 Mar;185:109804. doi: 10.1016/j.diabres.2022.109804. Epub 2022 Feb 24.
PubMed 35219762
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Caloric Restriction on Metabolic, Renal End Retinal Health in Subjectsaffected by Obesityand Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01930136
- Acronym / sponsor ID
- CRESO2 / CRESO 2
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Calorie restriction, Type 2 diabetes, Obesity, Diabetic nephropathy prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Istituto Superiore di Sanità
- Study start
- May 2013 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 28 Aug 2013 (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 study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral obesity, insulin resistance, dyslipidemia, hypertension and inflammation.
The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on subjects at risk of nephropathy. Secondary aims are to better understand the relationship between CR and the following aspects: renal disease and its associated metabolic abnormalities, retinopathy and cardiovascular complications, quality of life and treatment cost.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calorie restriction (25%) | Experimental | Behavioral: Calorie restriction (25%)CR will correspond to a reduction of 25% from the total daily calorie expenditure calculated as Total Daily Energy Expenditure (TDEE) (kcal/d) using the formula from the validated Seven-Day Physical Activity Recall (PAR) Questionnaire (RMR x activity levels). |
| Ad libitum health diet | Active comparator | Behavioral: Ad libitum health diet |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >40 years;
- Type 2 diabetes (ADA criteria);
- UAE <300 mg/24h;
- Body mass index (BMI)>27kg/m2;
- Serum creatinine < 1.2 mg/dL;
Key exclusion criteria (17 listed)
- Concomitant non-diabetic renal disease or ischemic kidney disease;
- Primary or immune-mediated renal disease;
- Urinary tract obstruction or infection;
- Treatment with steroids and/or non-steroid anti-inflammatory agents;
- Treatment with thiazide or loop diuretics that, on the basis of the Investigator's judgment, might sustain hypovolemia and/or sodium depletion (with secondary kidney hypoperfusion/hypofiltration);
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 |
|---|---|---|
| Calorie restriction (25%) | Behavioural | Calorie restriction (25%) |
| Ad libitum health diet | Behavioural | Ad libitum health diet |
Primary outcome
The percent change in glomerular filtration rate (GFR) at month 6 versus baseline and the rate of GFR decline from month 6 to study end
Time frame: At baseline, 6, 12 and 24 month
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 6 May 2022.
- Derived from this study: PubMed 35219762Ruggenenti P, Cortinovis M, Trillini M, Parvanova A, Abbate M, Satriano C, Salvetti F, Bossi AC, Trevisan R, Perna A, Peracchi T, Rubis N, Diadei O, Martinetti D, Gaspari F, Fontana L, Remuzzi G; CRESO 2 Study; Organization. Long-term kidney and systemic effects of calorie restriction in overweight or obese type 2 diabetic patients (C.Re.S.O. 2 randomized controlled trial). Diabetes Res Clin Pract. 2022 Mar;185:109804. doi: 10.1016/j.diabres.2022.109804. Epub 2022 Feb 24.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie restriction (25%) and Ad libitum health diet in people with Type 2 Diabetes and Obesity, run by Mario Negri Institute for Pharmacological Research 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 9 inclusion and 17 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 6 May 2022. 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?
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?
The percent change in glomerular filtration rate (GFR) at month 6 versus baseline and the rate of GFR decline from month 6 to study end (time frame: At baseline, 6, 12 and 24 month). 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 NCT01930136, 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 6 May 2022.