NCT02580266

Brief Summary

Diabetic nephropathy (kidney problems caused by diabetes) is a devastating chronic vascular complication of diabetes. New treatments are urgently needed for preventing or slowing down the progression of diabetic kidney disease. Samples of serum/plasma/urine will be obtained from patients with diabetes and different degree of renal impairment. In this project cells in culture will be treated with plasma or serum or urine; cells extracts or supernatant will be studied to screen for modulation (activation/inhibition) of different cellular pathways using gene array, metabolomic and/or proteomic. Once some cellular pathways have been identified specific analysis will be conducted on the biological material collected to confirm specific "cell signatures" that could represent potential target for treatment.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

10 years

First QC Date

October 5, 2015

Last Update Submit

February 14, 2019

Conditions

Diabetes Complications

Keywords

KidneyDiabetes

Outcome Measures

Primary Outcomes (1)

  • Cellular phenotype

    Cellular phenotype (gene and protein expression level)

    5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with type 1 and type 2 diabetes

You may qualify if:

  • type 1 and type 2 diabetes

You may not qualify if:

  • major acute cardio (myocardial infarct, stroke, ec) renal (acute renal failure) events, or severe debilitating disease (e.g. cancer) during the 6 months before the blood/urine collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Metabolic Medicine, King's College London

London, SE1 9RT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, urine

MeSH Terms

Conditions

Diabetes ComplicationsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Endocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Luigi Gnudi, MD, PhD

    King's College London

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 20, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

GB(1)