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NCT01131052 · ClinicalTrials.gov registry record · Phase 4

Diabetes in the Elderly: Prospective Study

A Phase 4 study of Diabetes and Hyperglycemia, sponsored by Guillermo Umpierrez.

Completed
Registry status
Phase 4
Development phase
150
Enrollment target
1
Study location

NCT01131052 is a Phase 4 study of Diabetes and Hyperglycemia that has completed, run by Guillermo Umpierrez. The registered enrollment target is 150 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01131052, a Phase 4 study of Diabetes and Hyperglycemia, has completed, sponsored by Guillermo Umpierrez.

COMPLETED
Registry status
Phase 4
Development phase
150 participants
Enrollment target
1
Study location

Study Summary

Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults \>80years of age. It is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing. Nursing home residents with diabetes have higher rates of serious comorbidities and have greater activity of daily living dependencies than other residents without diabetes. In addition, persons with diabetes have higher risk of hypertension, heart disease, stroke depression, cognitive impairment, and cardiovascular mortality than individuals without diabetes. There are a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities; however, no previous randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities. In addition, it is not known whether the use of basal insulin is superior to treatment with sliding scale insulin (SSI) in long-term care facility residents with type 2 diabetes. Accordingly, the investigators propose to conduct a prospective randomized control trial comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale regular insulin in the management of nursing home patients with T2DM.

Conditions Studied

Diabetes Hyperglycemia

Interventions

  • DRUG Insulin
  • DRUG Insulin Glargine
  • DRUG Insulin glulisine

Study Locations (1)

Georgia

  • Guillermo Umpierrez - Atlanta

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2011-03
Est. Completion 2013-12
Phase Phase 4

Sponsor

Guillermo Umpierrez

2 total trials

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What the Registry Record Tells You About NCT01131052

The ClinicalTrials.gov registry entry for NCT01131052 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (95% lower). The listed sponsor is Guillermo Umpierrez, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Insulin is the first listed.

NCT01131052 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT01131052 about?

NCT01131052 is a clinical study titled "Diabetes in the Elderly: Prospective Study". Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults \>80years of age. It is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing. Nursing home residen...

What is the current status of trial NCT01131052?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2011-03. Estimated completion is 2013-12.

What conditions does trial NCT01131052 study?

This clinical trial studies the following conditions: Diabetes, Hyperglycemia.

What interventions are being tested in trial NCT01131052?

The interventions under investigation include: Insulin (DRUG), Insulin Glargine (DRUG), Insulin glulisine (DRUG).

Who is sponsoring clinical trial NCT01131052?

This trial is sponsored by Guillermo Umpierrez, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01131052 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.