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Trial record 43 of 7958 for:    "observation"

Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy

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ClinicalTrials.gov Identifier: NCT02307110
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Dr. med. Katja Hatz, Vista Klinik

Brief Summary:

This study is designed to evaluate the prevalence of different stages of diabetic retinopathy and diabetic macular edema among patients suffering from type 1 diabetes (DM 1) for 5 to 25 years and have been treated with intensified insulin therapy aiming near-normal blood glucose levels for the whole duration of disease.

Prevalence of different stages of diabetic retinopathy and diabetic macular edema is assessed using the modified Airlie House classification and the Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy severity scheme. Results of this study will provide the basis for designing further studies as well as staging and screening guidelines for diabetic retinopathy/diabetic macular edema.


Condition or disease Intervention/treatment Phase
Insulin-Dependent Diabetes Mellitus 1 Other: cross-sectional observation Not Applicable

Detailed Description:

Purpose: This study is designed to evaluate the prevalence of different stages of diabetic retinopathy and diabetic macular edema among patients suffering from type 1 diabetes for 5 to 25 years and have been treated with intensified insulin therapy aiming near-normal blood glucose levels for the whole duration of disease.

Objectives: The primary objective is to examine the prevalence (percentages) of the stages of diabetic retinopathy (DR) and diabetic macular edema (DME) within one cross-sectional examination. Key secondary/exploratory objectives are the prevalence (percentages) of the stages of diabetic macular edema (DME), the means of individual average 5year-/10year-/15year-/20year-/25year-HbA1c value (%) as a measure for long-term glycemic control, the means of individual average 5year-/10year-/15year-/20year-/25year-blood pressure (mmHg) as a measure for long-term blood pressure control, mean BCVA score, mean contrast sensitivity score, mean NEI-VFQ 25 score (for further details see section Objectives).

Study design: Non-interventional cross-sectional investigator initiated study. The study will be conducted at Vista Klinik Binningen/Switzerland (ophthalmological evaluations) and the Department of Endocrinology of the University Hospital Basel/Switzerland (patient recruitment).

Study population: All patients with DM Type 1 with a least 5 years and maximum 25 years disease duration and intensified insulin therapy for the whole duration of disease, who are currently in follow-up for their DM1 at Department of Endocrinology of the University Hospital Basel/Switzerland. In order to prevent selection bias, patients will be screened for enrollment consecutively. For In-/exclusion criteria see section Eligibility.

Investigational and reference therapy: None.

Assessments:

  • Visual acuity measurements using the ETDRS-like testing charts at a test distance of 4 meters
  • Contrast sensitivity
  • Ophthalmic examinations (slit lamp exam with fundus biomicroscopy, intraocular pressure)
  • High resolution optical coherence tomography (Spectralis-OCT)
  • Stereoscopic fundus photography
  • Fluorescein angiography
  • NEI-VFQ 25 (25-item National Eye Institute Vision Function Questionnaire)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Cross Sectional Study Assessing the Prevalence of Different Stages of Diabetic Retinopathy and Diabetic Macular Edema Among Type 1 Diabetic Patients Treated With Long-term Intensified Insulin Therapy
Actual Study Start Date : August 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
1 arm study
cross-sectional observation
Other: cross-sectional observation
cross-sectional opthalmic examination
Other Name: observational study.




Primary Outcome Measures :
  1. prevalence (percentages) of the stages of diabetic retinopathy (DR) [ Time Frame: one cross-sectional examination only ]

Secondary Outcome Measures :
  1. prevalence (percentages) of the stages of diabetic macular edema (DME) [ Time Frame: one cross-sectional examination only ]
    The outcome is evaluated for different patient groups relating to the duration of DM1 disease (5-10 years, 11-15 years, more than 15 years).

  2. means of individual average 5year-/10year-/15year-/20year-/25year-HbA1c value (%) [ Time Frame: 5year-/10year-/15year-/20year-/25year ]
    as a measure for long-term glycemic control

  3. the means of individual average 5year-/10year-/15year-/20year-/25year-blood pressure (mmHg) [ Time Frame: 5year-/10year-/15year-/20year-/25year ]
    as a measure for long-term blood pressure control

  4. mean BCVA score [ Time Frame: one cross-sectional examination only ]
    The outcome is evaluated for different patient groups relating to the duration of DM1 disease (5-10 years, 11-15 years, more than 15 years).

  5. mean contrast sensitivity score [ Time Frame: one cross-sectional examination only ]
    The outcome is evaluated for different patient groups relating to the duration of DM1 disease (5-10 years, 11-15 years, more than 15 years).

  6. mean NEI-VFQ 25 score [ Time Frame: one cross-sectional examination only ]
    The outcome is evaluated for different patient groups relating to the duration of DM1 disease (5-10 years, 11-15 years, more than 15 years).



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients >18 years of age who have signed an informed consent
  • Patients with type 1 diabetes mellitus diagnosed between 5 and 25 years prior to screening who were on intensified insulin therapy (multiple daily insulin injections or insulin pump) from the beginning of the disease

Exclusion Criteria:

  • Patients with hypertension and a change in antihypertensive treatment within 2 months pre-enrollment should not be enrolled unless blood pressure is maintained for at least 1 month below 160/100 mm Hg by antihypertensive treatment
  • Patients with a history of chronic renal failure requiring dialysis or kidney transplantation if there is a risk for the patient to perform fluorescein angiography (discretion of the endocrinological investigator)
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml)
  • History of allergy to fluorescein
  • Inability to obtain fundus photographs, fluorescein angiograms or OCT images of sufficient quality to be analyzed and graded
  • Inability to comply with study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307110


Locations
Switzerland
Vista Klinik
Binningen, Switzerland, 4102
Sponsors and Collaborators
Vista Klinik
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Katja Hatz, MD Vista Klinik Binningen

Responsible Party: Dr. med. Katja Hatz, Prof. Dr. Christian Pruente, Vista Klinik
ClinicalTrials.gov Identifier: NCT02307110     History of Changes
Other Study ID Numbers: DRP-2010-02
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

Keywords provided by Dr. med. Katja Hatz, Vista Klinik:
Diabetes Mellitus 1
long-term intensified insulin therapy
diabetic retinopathy
diabetic macular edema

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Retinopathy
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs