Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01517490

Enrollment

100

Registered

2012-01-25

Start date

2011-08-31

Completion date

Unknown

Last updated

2015-03-11

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

Conditions

Diabetes Mellitus, Diabetic Retinopathy

Brief summary

Retinal function is highly dependent on the glucose supply. Thus, functional adaptations occur in response to both acute and long-term changes in glycaemia. The purpose of this study is to examine functional and metabolic aspects of retinal adaptation to long-lasting changes in glycaemic control in patients with diabetes. The adaptational phenomena will be characterized by electroretinography, dark adaptation, measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and (OCT).

Interventions

OTHERInsulin pump

Insulin pump therapy

OTHERMultiple daily insulin injections

Multiple daily insulin injections

PROCEDUREBariatric surgery

Pre-operative weight loss and bariatric surgery.

OTHERMedical therapy for type 2 diabetes

Medical glucose-lowering therapy and non-surgical weight-lowering interventions.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with type 1 diabetes and suboptimal metabolic regulation. * Patients with type 2 diabetes and suboptimal metabolic regulation.

Exclusion criteria

* Significant cataract * Glaucoma * Proliferative diabetic retinopathy fulfilling ETDRS treatment criteria. * Clinically significant macular edema fulfilling ETDRS treatment criteria. * Age-related macular degeneration * Prior surgery to the eye * Other serious eye disease * Hypertension

Design outcomes

Primary

Measure	Time frame
Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry.	Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months
Changes in visual acuity, diabetic retinopathy grading and OCT	Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months

Countries

Denmark

Contacts

Primary ContactOliver Klefter, MD

+45 38 63 48 18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026