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Trial record 3 of 50 for:    diabetes type 1 AND (woman OR women OR female) AND blood glucose

An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics

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ClinicalTrials.gov Identifier: NCT03328975
Recruitment Status : Withdrawn (PI decided to withdraw study)
First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Bryson Lesniak, University of Pittsburgh

Brief Summary:
The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.

Condition or disease Intervention/treatment Phase
Shoulder Injury Insulin-dependent Diabetics Drug: Dexamethasone Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of Blood Glucose Levels and Insulin Requirement After Subacromial Corticosteroid Injection in Insulin Dependent Diabetics
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexamethasone
Group 1 will receive an injection of 4mg of dexamethasone 4 mL of 1% lidocaine.
Drug: Dexamethasone
The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.
Other Name: Corticosteroid

Placebo Comparator: Placebo
Group 2 will receive an injection of 5 mL of 1% lidocaine (placebo).
Other: Placebo
the placebo group will not receive the corticosteroid medication in their injection to treat the inflammation and pain in their shoulder. Instead, they will receive an injection of 5 mL lidocaine only.




Primary Outcome Measures :
  1. Can diabetic patients maintain their blood glucose in a normal range after receiving a corticosteroid injection? [ Time Frame: 4 weeks ]
    The main outcome variable in this study is to determine what effects, if any, a corticosteroid injection has on the ability of diabetic patients to maintain their blood glucose in a normal range. This will allow for better patient education when discussing the risks of corticosteroid injections and allow for improved post-injection care of patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Insulin-dependent diabetic
  • Age 18+
  • Shoulder pain for over 4 weeks duration that is uncontrolled with activity modification or nonsteroidal anti-inflammatory drugs
  • Use of glucometer for blood sugar monitoring
  • Well controlled blood glucose levels
  • Hemoglobin A1c less than or equal to 7.5

Exclusion Criteria

  • Previous corticosteroid injection within the past 6 months
  • Active infection
  • Pregnant or plan on becoming pregnant
  • Previous adverse event with corticosteroid or lidocaine use

Responsible Party: Bryson Lesniak, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03328975     History of Changes
Other Study ID Numbers: PRO17070506
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Shoulder Injuries
Wounds and Injuries
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Dexamethasone acetate
Dexamethasone
Lidocaine
BB 1101
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action