Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01711385
Other study ID # AAAD6446
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2009
Est. completion date June 2013

Study information

Verified date August 2021
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In an ongoing study new dental patients are screened to determine their risk of having undiagnosed pre-diabetes or diabetes based on risk factors readily known by the patient and signs of gum disease. Investigators further seek to assess if a post-identification intervention leads to a greater likelihood of study participants identified as potentially pre-diabetic or diabetic visiting their physician regarding their screening blood test results, and to improved health outcomes.


Description:

Approximately 3% to 4% of the U.S. adult population has undiagnosed diabetes and the prevalence is likely to be substantially higher among people with risk factors for diabetes. Of note, many patients at the time of diagnosis of diabetes already have diabetic complications. This indicates that there is a period of "asymptomatic" diabetes during which hyperglycemia and other risk factors are present and complications are developing. This substantial delay in clinical diagnosis of diabetes involves a period of about 10-12 years that elapses between onset of diabetes and its diagnosis. Early diagnosis of diabetes, with treatment aiming at strict control of blood glucose levels, is important in preventing or mitigating its clinical complications and improving health outcomes. Oral findings may offer an unrealized opportunity for the identification of affected individuals unaware of their condition. Previous research suggests that oral healthcare professionals have the opportunity to identify unrecognized diabetes and pre-diabetes in dental patients and refer them to a physician for further evaluation and care. Based on these findings, efforts to identify dental patients' risk of having undiagnosed pre-diabetes or diabetes, using a new diagnostic blood test as the outcome (HPLC HbA1c), continue. In addition, a subgroup of study subjects identified as potentially pre-diabetic or diabetic are randomly assigned to either a group 1/basic-standard intervention arm or to a group 2/enhanced intervention arm. The investigators seek to determine if a post-identification intervention leads to a greater likelihood of study participants identified as potentially pre-diabetic or diabetic visiting their physician regarding their blood test results and to improved health outcomes. Results of this pilot study have the potential to set in motion far ranging, changes in the practice of dentistry, leading to the advancement of a new paradigm in dental practice that calls for the adoption of a more holistic approach to patient care.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date June 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - Patient who presents at the Columbia University College of Dental Medicine dental clinic - Never been told that pre-diabetic or diabetic - 40 years old or older, if white - 30 years old or older, if non-white - If female, not pregnant - Not completely edentulous - Able to undergo a periodontal examination Exclusion Criteria: - Previously told by physician that prediabetes or diabetes is present - < 40 years of age if non-hispanic and white, and < 30 years of age if hispanic or non-white - For medical or other reasons cannot tolerate a periodontal exam - If female, pregnant - Fully edentulous

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced intervention
Study patients are notified of their blood test result within 72 hours. Those identified as potentially pre-diabetic or diabetic, and randomized to the enhanced intervention arm, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results or are provided with a referral to one. They are given a letter to take to their physician that specifies the risk factors identified, the tests carried out for the patient and the exact numeric results. They receive a call at month 2 to see if they have followed up with a physician regarding their test results. If they have not seen a physician regarding their results, they are advised again to do so and reminded of their individual risk factors. At month 4 they are asked again if they have seen a physician regarding their test results. If they still have not seen a physician at this time the message is reinforced. They are contacted again by phone to schedule the 6-month recall visit.

Locations

Country Name City State
United States Columbia University College of Dental Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of follow-up visit to physician regarding screening result Investigators want to determine if the enhanced intervention increases the likelihood that study participants identified as potentially pre-diabetic or diabetic visit their physician to discuss the screening results of their and to receive advice from their physician, relative to participants in the standard practice group. Baseline up to six months
Secondary Decrease in HbA1c Investigators want to determine if study participants who receive the enhanced intervention have an improved HbA1c test result, relative to standard practice group participants, upon re-testing during a second study visit at 6 months. Baseline up to six months
Secondary Improved periodontal measures Investigators want to determine if the participants who receive the enhanced intervention are found to have improved periodontal findings, relative to standard practice group participants, upon re-examination during a second study visit at 6 months. Baseline up to six months
See also
  Status Clinical Trial Phase
Completed NCT05424107 - A Mediterranean Intervention on Prediabetic Children N/A
Recruiting NCT02681887 - Effect of Melatonin on Cardiometabolic Risk- FULL Phase 3
Completed NCT04088461 - Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine Phase 4
Recruiting NCT02561377 - Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics) N/A
Completed NCT02678390 - Medium Chain Triglycerides and Aerobic Exercise on Ketone Production in Women With or Without Prediabetes N/A
Completed NCT02551640 - Improving Physical Activity Through a mHealth Intervention in Cardio-metabolic Risk Patients N/A
Completed NCT02459691 - Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos) N/A
Completed NCT01671293 - Multicomponent Telecare Model for Supporting Prediabetes Patients N/A
Completed NCT01479933 - Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes N/A
Completed NCT00960973 - The Effect of Vitamin K Supplementation on Glucose Metabolism Phase 4
Completed NCT00455325 - Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS) Phase 2
Recruiting NCT05123963 - Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors N/A
Recruiting NCT05340868 - Genetics of the Acute Response to Oral Semaglutide N/A
Recruiting NCT04984421 - IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (IMPROVE) N/A
Recruiting NCT04134650 - Effect of Low Dose Combination of Linagliptin + Metformin to Prevent Diabetes Phase 3
Recruiting NCT04131582 - Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes Phase 3
Recruiting NCT05347030 - Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population N/A
Completed NCT04074148 - Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal N/A
Recruiting NCT05050266 - Enhancing Mental and Physical Health of Women Veterans N/A
Completed NCT02684565 - Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-Diabetic Subjects N/A