Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT00362193
Status:
COMPLETED
Last Update Posted:
2010-02-15
First Post:
2006-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glycemic Relapse Prevention: Maintenance Dose Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-12', 'studyFirstSubmitDate': '2006-08-07', 'studyFirstSubmitQcDate': '2006-08-07', 'lastUpdatePostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic relapse: increase in HbA1c by 1% over baseline and >8%'}], 'secondaryOutcomes': [{'measure': 'Height/Weight'}, {'measure': 'Waist/Hip Circumference'}, {'measure': 'Systolic/Diastolic BP'}, {'measure': 'Demographic variables'}, {'measure': 'Duration of Diabetes (years)'}, {'measure': 'Hypoglycemia'}, {'measure': '3-day food record'}, {'measure': 'SF-36'}, {'measure': 'Self Efficacy'}, {'measure': 'Medication'}, {'measure': 'Medication Adherence'}, {'measure': 'Exercise'}, {'measure': 'Self-monitoring blood glucose (obtained from DIP records)'}, {'measure': 'Fasting Lipid Panel'}]}, 'conditionsModule': {'keywords': ['Diabetes', 'Chronic disease management', 'Relapse'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '20084363', 'type': 'DERIVED', 'citation': 'Huizinga MM, Gebretsadik T, Garcia Ulen C, Shintani AK, Michon SR, Shackleford LO, Wolff KL, Brown AW, Rothman RL, Elasy TA. Preventing glycaemic relapse in recently controlled type 2 diabetes patients: a randomised controlled trial. Diabetologia. 2010 May;53(5):832-9. doi: 10.1007/s00125-010-1658-3. Epub 2010 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse.', 'detailedDescription': "Recent large randomized controlled trials have proven that tight glycemic control reduces the microvascular and macrovascular complications of diabetes. Reduction of these complications also leads to a great cost savings to healthcare and society. However, it has been difficult to translate the success of these large randomized control trials to everyday practice. A recent cross-sectional analysis of 95 clinicians revealed only 40.5% of type 2 diabetes patients had a glycated hemoglobin (HbA1c) less than 7%. The disparity of care between the large trials and a primary care office is largely due to the difference in resources available in the typical medical office. Practical, sustainable ways of maintaining tight glycemic control are needed in everyday practice.\n\nWhile diabetes improvement programs are successful in acutely lowering HbA1c the long-term effectiveness of these programs is disappointing. Approximately 40% of those who return to routine care after completing an intensive diabetes improvement program experience a relapse in their glycemic control within one year. Some proportion of the relapse is likely due to a patient's inability to maintain adherence to key self-care behaviors - diet, exercise, self-monitoring of blood glucose and medication regimen.\n\nThe purpose of this study is to better understand prevention of glycemic relapse. The primary aim of this study is to assess the relative effectiveness of three management approaches, varying in frequency, for preventing glycemic relapse after glycemic control has been achieved through participation in an intensive diabetes improvement program. This study will determine the optimal frequency of intervention needed to prevent glycemic relapse in patients with type 2 diabetes. The authors hypothesize that high intensity intervention will lead to a decrease in glycemic relapse in a dose dependent fashion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Recent control obtain (HbA1c\\<8%) after diabetes improvement program\n* Receives care in primary care clinic\n\nExclusion Criteria:\n\n* pregnant'}, 'identificationModule': {'nctId': 'NCT00362193', 'briefTitle': 'Glycemic Relapse Prevention: Maintenance Dose Assessment', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse', 'orgStudyIdInfo': {'id': 'DK62258 (completed)'}, 'secondaryIdInfos': [{'id': 'P60DK020593', 'link': 'https://reporter.nih.gov/quickSearch/P60DK020593', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Telephonic diabetes care', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tom A Elasy, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'Vanderbilt University', 'class': 'OTHER'}]}}}