Recruiting

Observational Study

Sponsor:

University of the Pacific

Code:

NCT04790760

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Supplement Consumption

Continuous Glucose Monitors

Study Details

Brief summary:

Continuous glucose monitoring (CGM) is an emerging field for diabetes management. CGMs are small devices primarily placed on a patient's upper arm that allow providers and patients to individualize therapy by looking at real time glucose levels. While the accuracy of these devices is extensively researched, there are no large-scale studies evaluating the differences between left and right arm glucose readings in the diabetic population. Additionally cinnamon and aloe vera are supplements commonly used by diabetic patients to help improve glycemic control. However, there remains a shortage of studies researching the effects of cinnamon and aloe vera on diabetic patients' glycemic control.

The purpose of this study is to determine if there is a difference between glucose levels in the right arm and left arm in diabetic patients and to evaluate if cinnamon and aloe vera supplements impact glycemic control in diabetic patients.

Conditions

Diabetes

Study ID

NCT04790760

Start date

Mar, 2021

Status verified date

Feb, 2021

Completion date

Feb, 2022

Anticipated

Primary completion date

Feb, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult 18-65 years of age
  • Diagnosed with type 2 diabetes
  • Willing to wear CGM for 6 weeks on both arms
  • Willing to come in for 4 office visits over 6 weeks
  • Willing to consume assigned supplement twice a day for 4 weeks
  • Willing to receive and respond to daily text messages or maintain a daily study log of supplement consumption
  • Have active health insurance
  • Willing to refrain from any heat therapy for the duration of the study
  • Willing to refrain from taking any other supplements that are deemed by the investigator to alter glucose for the duration of the study
  • Willing to refrain from consuming ascorbic acid and salicylic acid for the duration of the study due to a known interaction with CGMs
  • Be able to self-monitor blood glucose with finger-stick method
  • Have a baseline HbA1c > 6.5%

Exclusion Criteria:

  • Any active dermatologic condition on the upper arms
  • Implanted medical devices (i.e. pacemaker)
  • Critically ill or dialysis patients
  • Planned magnetic resonance imaging screening, computed tomography scan, x-ray imaging or high-frequency electrical heat treatment during study period
  • Current systemic infections
  • Participants who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
  • Change in diabetic medication regimen within the previous 30 days (except insulin)
  • Self-identified allergy to cinnamon or aloe vera
  • Refusal to sign the informed consent document
  • Pregnant, planned-pregnancy during study period or currently breast-feeding
  • History of hypoglycemic episodes warranting medical attention experienced in the last 30 days

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Continuous Glucose Monitoring

Participants will wear a CGM device on the back of both their left and right arm for 6 weeks.

Interventions

Supplement Consumption

Participants will consume one 500 mg cinnamon capsule and one 300 mg aloe vera capsule twice per day for weeks 3-6.

Continuous Glucose Monitors

Participants will wear a CGM on the back of their left and right arm for weeks 1-6.

Primary outcome measure

  • Difference in time-matched glucose levels between the right arm and the left arm [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Sachin Shah, PharmD

7074233277sshah@pacific.edu

Elizabeth Lindemann

7074233277e_lindemann@u.pacific.edu

Locations

Manshadi Heart Institute, Inc.

Recruiting

Stockton, California, United States, 95204

More Information

Sponsor

University of the Pacific

Last update posted

Mar 10, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of the Pacific on 2021-03-10.