Effects of dietary protein restriction on albumin and fibrinogen synthesis in macroalbuminuric Diabetes Mellitus type 2 (DM2) subjects

ISRCTN ISRCTN50205911
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

Pzza L. Miraglia, 2
Naples
80138
Italy

Email mauro.giordano@unina2.it

Study information

Study designInterventional, randomised prospective clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffects of dietary protein restriction on albumin and fibrinogen synthesis in macroalbuminuric Diabetes Mellitus type 2 (DM2) subjects
Study acronymDM2LPD study
Study objectivesDietary 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) studiedDiabetes mellitus and nephropathy
InterventionWe 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 typeOther
Primary outcome measureAlbumin and fibrinogen synthesis, measured at baseline and four weeks pre-LPD and post-LPD.
Secondary outcome measuresProteinuria and low-grade inflammation, measured at baseline and four weeks pre-LPD and post-LPD.
Overall study start date05/01/2005
Completion date07/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants10
Total final enrolment15
Key inclusion criteriaEligibility 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 criteriaExclusion 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 enrolment05/01/2005
Date of final enrolment07/07/2006

Locations

Countries of recruitment

  • Italy

Study participating centre

Pzza L. Miraglia, 2
Naples
80138
Italy

Sponsor information

Second University of Naples (Seconda Universita degli studi di Napoli) (Italy)
University/education

Department of Geriatrics and Metabolism Diseases
Pzza l. miraglia, 2
Naples
80138
Italy

Email mauro.giordano@unina2.it
Website http://web.unina2.it/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.