NCT01065155

Brief Summary

Diabetic patients show an increased prevalence of non dipping arterial pressure pattern, target organ damage and elevated arterial stiffness. These alterations are associated with increased cardiovascular risk. The objectives of this study are the following: to evaluate the prognostic value of central arterial pressure and pulse wave velocity in relation to the incidence and outcome of target organ damage and the appearance of cardiovascular episodes (cardiovascular mortality, myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

February 6, 2010

Last Update Submit

February 20, 2020

Conditions

DiabetesCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular target organ damage (renal, cardiac and vascular) and new cardiovascular events

    four years

Study Arms (1)

Median central blood pressure

Median central blood pressure, lower median group 1 and higher group 2.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive inclusion will be made of the patients referred to the research unit and who meet the corresponding inclusion criteria, i.e., patients diagnosed with DM2 and aged 20-80 years A total of 52 patients are required in each group, estimating a loss to follow-up of 10%. A final total of 110 patients therefore will be included.

You may qualify if:

  • diagnosed of Diabetes Mellitus type 2, and
  • aged 20-80 years.

You may not qualify if:

  • psychological and/or cognitive disorders,
  • failure to cooperate,
  • educational limitations and problems for understanding written language, failure to sign the informed consent document
  • patients participating or who will participate in a clinical trial during the study,
  • patients with serious comorbidities representing a threat to life over the subsequent 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary care Research unit. La Alamedilla health centre

Salamanca, 37003, Spain

Location

Related Publications (4)

  • Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Gomez-Sanchez L, Gomez-Sanchez M, Garcia-Ortiz L; LOD-DIABETES Group. Evolution of target organ damage and haemodynamic parameters over 4 years in patients with increased insulin resistance: the LOD-DIABETES prospective observational study. BMJ Open. 2016 Jun 1;6(6):e010400. doi: 10.1136/bmjopen-2015-010400.

    PMID: 27251684DERIVED

  • Gomez-Marcos MA, Recio-Rodriguez JI, Gomez-Sanchez L, Agudo-Conde C, Rodriguez-Sanchez E, Maderuelo-Fernandez J, Gomez-Sanchez M, Garcia-Ortiz L; LOD-DIABETES Group. Gender differences in the progression of target organ damage in patients with increased insulin resistance: the LOD-DIABETES study. Cardiovasc Diabetol. 2015 Oct 1;14:132. doi: 10.1186/s12933-015-0293-1.

    PMID: 26427534DERIVED

  • Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Agudo-Conde C, Gomez-Sanchez L, Gomez-Sanchez M, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Garcia-Ortiz L; LOD-DIABETES Group. Cardio-ankle vascular index is associated with cardiovascular target organ damage and vascular structure and function in patients with diabetes or metabolic syndrome, LOD-DIABETES study: a case series report. Cardiovasc Diabetol. 2015 Jan 16;14:7. doi: 10.1186/s12933-014-0167-y.

    PMID: 25853841DERIVED

  • Gomez-Marcos MA, Recio-Rodriguez JI, Rodriguez-Sanchez E, Castano-Sanchez Y, de Cabo-Laso A, Sanchez-Salgado B, Rodriguez-Martin C, Castano-Sanchez C, Gomez-Sanchez L, Garcia-Ortiz L. Central blood pressure and pulse wave velocity: relationship to target organ damage and cardiovascular morbidity-mortality in diabetic patients or metabolic syndrome. An observational prospective study. LOD-DIABETES study protocol. BMC Public Health. 2010 Mar 18;10:143. doi: 10.1186/1471-2458-10-143.

    PMID: 20298558DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine).

MeSH Terms

Conditions

Diabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Manuel A Gomez, MD

    Fundacion para la investigación y formacion en ciencias de la salud

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 6, 2010

First Posted

February 9, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2014

Study Completion

March 1, 2016

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

ES(1)