Skin and Retina Microvascular Endothelial Function in Healthy, Insulin Resistant and Type 2 Diabetic Subjects

NCT01241370 | Completed

• 1 other identifier: IKFE-RET-001
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate microvascular endothelial function in the retina of lean, obese, and type 2 diabetic subjects and to compare microvascular endothelial function in the retina with several other established markers of endothelial and microvascular function.

Conditions

Diabetes Mellitus, Type 2

Keywords

Retinal endothelia dysfunction; Type 2 diabetes mellitus; Insulin-resistance; micro-lightguide spectrophotometry; laserdopplerfluxmetry

Outcome Measures

Primary Outcomes (1)

• Comparison of retinal microvascular endothelial function in obese insulin sensitive, insulin-resistant and type 2 diabetic subjects with retinal microvascular endothelial function in lean healthy control subjects.

  Measurements were taken from the superficial retinal layer (300 µm) using a scanning laser doppler flowmetry at 720 nm (Heidelberg Retina Flowmeter, Heidelberg Engineering)

  2-28 days

Secondary Outcomes (4)

• Comparison of microvascular endothelial function in the skin in obese and type 2 diabetic subjects with microvascular endothelial function in lean healthy control subjects.

  2-28 days

• Comparison of microvascular endothelial function in the retina with microvascular endothelial function in the skin in diabetic and in non-diabetic subjects.

  2-28 days

• Comparison of morphologic changes in retinal vessels (atrio-venous-ratio, diameter) in diabetic and in non-diabetic subjects.

  2-28 days

• Comparison of the Oral Glucose Tolerance Test (OGTT) in the different subject groups with skin and retinal endothelial function.

  2-28 days

Study Arms (3)

Lean healthy subjects

Homeostasis Model Assessment score (HOMAs) ≤ 2, Body Mass Index (BMI) ≤ 28 kg/m2

Insulin-resistnat subjects

HOMAs \> 2, BMI \> 28 kg/m2

Type 2 diabetic patients

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is planned to recruit up to 60 obese male and female subjects, stratified according to the following, 20 non-diabetic subjects with HOMAs ≤ 2, BMI \< 28 kg/m² 20 non-diabetic subjects with HOMAs \> 2, BMI ≥ 28 kg/m² 20 type 2 diabetic patients

You may qualify if:

• Age: 30 to 70 years
• Have given informed consent to participate in this study in accordance with local regulations
• Are reliable and willing to make themselves available for the duration of the study and will abide by the study restrictions

You may not qualify if:

• Smoking within the last 6 months
• Pre-proliferative or proliferative diabetic retinopathy
• Have a history of drug or alcohol abuse within the last 5 years
• Pregnant or intend to become pregnant during the course of the study
• Have a condition (including known drug abuse, alcohol abuse, or psychiatric disorder) which, in the opinion of the investigator, precludes the patient from following and completing the protocol
• Epilepsy
• Lack of compliance or another, similar reason, that, in the judge of the investigator, precludes satisfactory participation in the study.
• Treatment with nitrates, angiotensin converting enzyme (ACE)-inhibitors, or angiotensin (AT) II blockers
• Treatment with glitazones

Sponsors & Collaborators

• ELAB-Logistics: lead
• Institute for Clinical Research and Development (ikfe) GmbH: collaborator
• Johannes Gutenberg University Mainz: collaborator
• University of Erlangen-Nürnberg Medical School: collaborator

Study Sites (1)

ikfe GmbH, clinic

Mainz, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Thomas Forst, MD

  Ikfe GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 16, 2010
• Study Start: May 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: November 16, 2010

Record last verified: 2010-11

Locations

DE (1)