Effects of dietary protein restriction on albumin and fibrinogen synthesis in macroalbuminuric Diabetes Mellitus type 2 (DM2) subjects
ISRCTN | ISRCTN50205911 |
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DOI | https://doi.org/10.1186/ISRCTN50205911 |
Secondary identifying numbers | diab-07-0804 |
- Submission date
- 06/09/2007
- Registration date
- 19/11/2007
- Last edited
- 10/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mauro Giordano
Scientific
Scientific
Pzza L. Miraglia, 2
Naples
80138
Italy
mauro.giordano@unina2.it |
Study information
Study design | Interventional, randomised prospective clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Effects of dietary protein restriction on albumin and fibrinogen synthesis in macroalbuminuric Diabetes Mellitus type 2 (DM2) subjects |
Study acronym | DM2LPD study |
Study objectives | Dietary protein restriction on albumin and fibrinogen synthesis. |
Ethics approval(s) | Approval received from the Ethics committee of Second University of Naples (Comitato Etico Azienda Ospedaliera Universitaria - SUN) in 2005. |
Health condition(s) or problem(s) studied | Diabetes mellitus and nephropathy |
Intervention | We compared the effects of a Normal Protein Diet (NPD) (1.38 ± 0.08 g/kg/day) or a Low Protein Diet (LPD) (0.81 ± 0.04 g/kg/day) on Endogenous Leucine Flux (ELF), albumin and fibrinogen synthesis (5,5,5,-D3-L-leucine infusion), and markers of inflammation, in 9 subjects with DM2 and macroalbuminuria. The duration of treatment is 4 weeks pre-LPD and 4 weeks post-LPD. The total duration of follow-up for all treatment arms is 8 weeks. |
Intervention type | Other |
Primary outcome measure | Albumin and fibrinogen synthesis, measured at baseline and four weeks pre-LPD and post-LPD. |
Secondary outcome measures | Proteinuria and low-grade inflammation, measured at baseline and four weeks pre-LPD and post-LPD. |
Overall study start date | 05/01/2005 |
Completion date | 07/07/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 10 |
Total final enrolment | 15 |
Key inclusion criteria | Eligibility criteria of type 2 diabetic patients included: 1. Body Mass Index (BMI) less than 35 kg/m^2 2. Proteinuria greater than 3 g/day 3. Absence of urinary tract infection or other renal diseases Age range and gender of our participants are: 1. DM2 (60 ± 2 years): 6 males, 3 females 2. Control (37 ± 3 years): 3 males and 3 females |
Key exclusion criteria | Exclusion criteria of type 2 diabetic patients included: 1. BMI greater than 35 kg/m^2 2. Proteinuria less than 3 g/day |
Date of first enrolment | 05/01/2005 |
Date of final enrolment | 07/07/2006 |
Locations
Countries of recruitment
- Italy
Study participating centre
Pzza L. Miraglia, 2
Naples
80138
Italy
80138
Italy
Sponsor information
Second University of Naples (Seconda Universita degli studi di Napoli) (Italy)
University/education
University/education
Department of Geriatrics and Metabolism Diseases
Pzza l. miraglia, 2
Naples
80138
Italy
mauro.giordano@unina2.it | |
Website | http://web.unina2.it/ |
https://ror.org/05290cv24 |
Funders
Funder type
University/education
Second University of Naples (Seconda Universita degli studi di Napoli) (Italy) - Department of Geriatrics and Metabolism Diseases
No information available
Italian Ministry for University and Scientific Research (MIUR) (Italy) (ref: PRIN prot. 2004060902_005)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 01/01/2008 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference and total final enrolment added.