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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50205911
Enrollment
10
Registered
2007-11-19
Start date
2005-01-05
Completion date
Unknown
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus and nephropathy Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

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

Sponsors

Second University of Naples (Seconda Universita degli studi di Napoli) (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Albumin and fibrinogen synthesis, measured at baseline and four weeks pre-LPD and post-LPD.

Secondary

MeasureTime frame
Proteinuria and low-grade inflammation, measured at baseline and four weeks pre-LPD and post-LPD.

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026