Blood Glucose Differences Between Left Arm and Right Arm Using a Continuous Glucose Monitor

NCT04102657 | Unknown FDA Device

• 1 other identifier: 20-04
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Interest in continuous glucose monitors (CGMs) is growing for use in evaluating real time glucose levels and in detecting extreme high and low values. A CGM is a small device primarily placed on the patient's upper arm or abdomen to measure glucose at frequent time intervals. While the accuracy of these devices is researched extensively, there are no large-scale studies evaluating the differences in the right and left arm in terms of device placement. In addition, intermittent fasting has gained popularity due to potential health benefits including reductions in weight, cholesterol, and blood glucose. However, there remains a shortage of studies researching the effect of short-term intermittent fasting on body fat. The purpose of this study is to see if there is a difference between glucose levels in the right arm and left arm and to examine if short-term intermittent fasting may impact an individual's body fat percentage.

Conditions

Diabetes

Keywords

CGM; Glucose Monitoring; Intermittent Fasting; Fasting; Exercise

Outcome Measures

Primary Outcomes (2)

• Difference in time-matched glucose levels between the right arm and left arm

  12-14 days

• Difference in body-fat percentage before and after 12-14 days of designated diet

  12-14 days

Secondary Outcomes (14)

• Difference in glucose readings between the right arm and left arm before and after 20-minutes of unilateral arm exercise

  12-14 days

• Difference in glucose readings between the right arm and left arm per designated diet

  12-14 days

• Change in Body Mass Index before and after 12-14 days of designated diet

  12-14 days

• Change in Body Fat Analysis before and after 12-14 days of designated diet

  12-14 days

• Difference in percent of total glucose readings in hypoglycemic range (Interstitial BG <70mg/dL) between the right arm and left arm

  12-14 days

Study Arms (4)

Intermittent Fasting with Left Arm Exercise

EXPERIMENTAL

Healthy volunteers willing to fast for a 16-hour period daily for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily.

Other: Intermittent Fasting; Other: Left Arm Exercise

Intermittent Fasting with Right Arm Exercise

EXPERIMENTAL

Healthy volunteers willing to fast for a 16-hour period daily for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily.

Other: Intermittent Fasting; Other: Right Arm Exercise

Free-living Diet with Left Arm Exercise

EXPERIMENTAL

Healthy volunteers maintaining their current diet for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily.

Other: Free-Living Diet; Other: Left Arm Exercise

Free-living Diet with Right Arm Exercise

EXPERIMENTAL

Healthy volunteers maintaining their current diet for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily.

Other: Free-Living Diet; Other: Right Arm Exercise

Interventions

Intermittent Fasting OTHER

Participants will be instructed to limit their daily food consumption to an 8-hour period in the day of their choosing. For the 16-hour fasting period, subjects are to eliminate caloric intake.

Intermittent Fasting with Left Arm Exercise; Intermittent Fasting with Right Arm Exercise

Free-Living Diet OTHER

Participants will maintain their current daily food consumption with no caloric restriction. Patient must not have participated in a specialized diet or weight loss program within 2 weeks of enrollment.

Free-living Diet with Left Arm Exercise; Free-living Diet with Right Arm Exercise

Left Arm Exercise OTHER

Participants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the left arm. In the middle of the study, participants will switch to the right arm to complete their unilateral arm exercises.

Free-living Diet with Left Arm Exercise; Intermittent Fasting with Left Arm Exercise

Right Arm Exercise OTHER

Participants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the right arm. In the middle of the study, participants will switch to the left arm to complete their unilateral arm exercises.

Free-living Diet with Right Arm Exercise; Intermittent Fasting with Right Arm Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-65 years of age
• Willing to wear CGM device for 12-14 days on both arms
• Have active health insurance
• Willing to refrain from any heat therapy for the duration of the study
• Having an interest to comply with the fasting requirements of the study as appropriate
• Willingness to maintain once daily email responses

You may not qualify if:

• 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
• Subjects 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
• Refusal to sign the informed consent document
• Pregnant, planned-pregnancy in the next 30 days, or breast-feeding
• Active eating disorder
• Taking any medications that have an increased risk of hypoglycemia (e.g. sulfonylureas, insulin, thiazolidinediones) as determined by the primary investigators
• Taking medications for obesity
• You have one of the following medical conditions that can cause rapid weight loss: rheumatoid arthritis, hyperthyroidism, irritable bowel syndrome, cancer, HIV, active tuberculosis, Addison's disease
• In an active weight loss program
• On a specialized diet (e.g. Weight Watchers, ketogenic diet, Atkins diet)
• Completed a specialized diet in the past 2 weeks (e.g. Weight Watchers, ketogenic diet, Atkins diet)

Sponsors & Collaborators

• University of the Pacific: lead

Study Sites (1)

University of the Pacific

Stockton, California, 95211, United States

RECRUITING

Related Publications (7)

• 2. Food and Drug Administration. Self-monitoring blood glucose test systems for over-the-counter use-guidance for industry and food and drug administration staff. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf. Accessed October 10, 2016.

  BACKGROUND

• 1. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D: The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care 2009;32:1378-1383

  BACKGROUND

• Rodbard D. Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities. Diabetes Technol Ther. 2016 Feb;18 Suppl 2(Suppl 2):S3-S13. doi: 10.1089/dia.2015.0417.

  PMID: 26784127 BACKGROUND

• Shapiro AR. Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe? J Diabetes Sci Technol. 2017 Jul;11(4):833-838. doi: 10.1177/1932296816688303. Epub 2017 Mar 1.

  PMID: 28540756 BACKGROUND

• Stote KS, Baer DJ, Spears K, Paul DR, Harris GK, Rumpler WV, Strycula P, Najjar SS, Ferrucci L, Ingram DK, Longo DL, Mattson MP. A controlled trial of reduced meal frequency without caloric restriction in healthy, normal-weight, middle-aged adults. Am J Clin Nutr. 2007 Apr;85(4):981-8. doi: 10.1093/ajcn/85.4.981.

  PMID: 17413096 BACKGROUND

• Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.

  PMID: 27737674 BACKGROUND

• Kawakatsu S, Liu X, Tran B, Tran BP, Manzanero L, Shih E, Shek A, Lim JJ. Differences in Glucose Readings Between Right Arm and Left Arm Using a Continuous Glucose Monitor. J Diabetes Sci Technol. 2022 Sep;16(5):1183-1189. doi: 10.1177/19322968211008838. Epub 2021 May 6.

  PMID: 33955249 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Intermittent Fasting; Fasting; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Central Study Contacts

Essie Liu, PharmD

CONTACT

707-423-3277; xliu2@pacific.edu

Sonoko Kawakatsu, PharmD

CONTACT

707-423-3277; skawakatsu@pacific.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: September 20, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)