Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04099550
Other study ID # PNUHEnMJMK1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 6, 2019
Est. completion date December 2021

Study information

Verified date April 2020
Source Pusan National University Hospital
Contact JEONG MI KIM, M.D
Phone 82-10-9431-3733
Email marse007@hanmail.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In Korea, 5 million adults aged 30 years or older have diabetes. The development and expansion of Korea's economy and society, has led to dramatic chances in people's lifestyle and diet habits, and an increase in life expectancy. However, changes in lifestyle and diet habits related to the improvements of socioeconomic status may contribute to an increased diabetes burden in Korea. Therefore, it is important to prevent diabetes.

The purpose of this study was to evaluate the effects of real time-continuous glucose measurement (RT-CGM) system compared to only lifestyle modification group on blood glucose, lipid profile and diabetes prevention in prediabetic adults with overweight or obesity.


Description:

Optimising patient adherence to prescribed lifestyle interventions to achieve improved blood glucose control remains a challenge. Combined use of real-time continuous glucose monitoring (RT-CGM) systems may promote improved glycaemic control.

Thirty adult with overweight or obesity and pre-diabetes are randomised to using either RT-CGM or self monitoring of blood glucose (SMBG) for 1 week with lifestyle intervention.

After 3 month, outcomes were glycemic control (HbA1c, fasting glucose), weight, and lipid profile assessed pre- and post-intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = BMI 23 kg/m2

- impaired fasting glucose (fasting glucose 100 to 125 mg/dL) or impaired glucose tolerance (2-h plasma glucose during oral glucose tolerance test (OGTT) 140 - 199 mg/dl) or HbA1c 5.7% to 6.4%

Exclusion Criteria:

- type 1 diabetes or type 2 diabetes or undergoing treatment for diabetes

- clinical history including malignancy

- fast history of cardiovascular disease (e.g. myocardial infarction, stroke), surgery, and trauma which may affect blood glucose within last 6 months

- taking medication (e.g. glucocorticoid, antipsychotics, anticholinergic drug etc.) which affect blood glucose

- acute infection within last 1 month

- pregnancy

Study Design


Intervention

Device:
RT-CGM
The group was monitored blood glucose initial 1-week with a RT-CGM.
Other:
SMBG
The group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.

Locations

Country Name City State
Korea, Republic of Jeong Mi Kim Busan

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858-62. — View Citation

Chase HP, Kim LM, Owen SL, MacKenzie TA, Klingensmith GJ, Murtfeldt R, Garg SK. Continuous subcutaneous glucose monitoring in children with type 1 diabetes. Pediatrics. 2001 Feb;107(2):222-6. — View Citation

Dagogo-Jack S, Egbuonu N, Edeoga C. Principles and practice of nonpharmacological interventions to reduce cardiometabolic risk. Med Princ Pract. 2010;19(3):167-75. doi: 10.1159/000285280. Epub 2010 Mar 29. Review. — View Citation

Gehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in Type 2 Diabetes--More Common Than You Think: A Continuous Glucose Monitoring Study. J Diabetes Sci Technol. 2015 Apr 27;9(5):999-1005. doi: 10.1177/1932296815581052. — View Citation

Hedayati SS, Elsayed EF, Reilly RF. Non-pharmacological aspects of blood pressure management: what are the data? Kidney Int. 2011 May;79(10):1061-70. doi: 10.1038/ki.2011.46. Epub 2011 Mar 9. Review. — View Citation

Lindström J, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinänen-Kiukaanniemi S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study (DPS). Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish Diabetes Prevention Study (DPS). Diabetologia. 2013 Feb;56(2):284-93. doi: 10.1007/s00125-012-2752-5. Epub 2012 Oct 24. — View Citation

Márquez-Celedonio FG, Téxon-Fernández O, Chávez-Negrete A, Hernández-López S, Marín-Rendón S, Berlín-Lascurain S. [Clinical effect of lifestyle modification on cardiovascular risk in prehypertensives: PREHIPER I study]. Rev Esp Cardiol. 2009 Jan;62(1):86-90. Spanish. — View Citation

Mayer-Davis EJ, Lawrence JM, Dabelea D, Divers J, Isom S, Dolan L, Imperatore G, Linder B, Marcovina S, Pettitt DJ, Pihoker C, Saydah S, Wagenknecht L; SEARCH for Diabetes in Youth Study. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Apr 13;376(15):1419-1429. doi: 10.1056/NEJMoa1610187. — View Citation

Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680. — View Citation

Rosenberg K. Prediabetes Increases Risk of Cardiovascular Disease. Am J Nurs. 2017 Jun;117(6):71. doi: 10.1097/01.NAJ.0000520262.18448.1c. — View Citation

Salkind SJ, Huizenga R, Fonda SJ, Walker MS, Vigersky RA. Glycemic variability in nondiabetic morbidly obese persons: results of an observational study and review of the literature. J Diabetes Sci Technol. 2014 Sep;8(5):1042-7. doi: 10.1177/1932296814537039. Epub 2014 May 29. Review. — View Citation

Tanenberg R, Bode B, Lane W, Levetan C, Mestman J, Harmel AP, Tobian J, Gross T, Mastrototaro J. Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. Mayo Clin Proc. 2004 Dec;79(12):1521-6. — View Citation

Yoon U, Kwok LL, Magkidis A. Efficacy of lifestyle interventions in reducing diabetes incidence in patients with impaired glucose tolerance: a systematic review of randomized controlled trials. Metabolism. 2013 Feb;62(2):303-14. doi: 10.1016/j.metabol.2012.07.009. Epub 2012 Sep 7. Review. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1C change All participants receive lifestyle intervention at week 0, week 4, and week 8. The intervention group was monitored initial 1 weeks with a RT-CGM and th control group continued self-monitoring blood glucose (SMBG) at least 2 times a day for 1 week.
HbA1c at baseline (week 0) and end of intervention (week 12).
Outcomes were assessed at baseline (week 0) and end of intervention (week 12)
Primary Weight (Kg) change weight change (Kg) at baseline (week 0) and end of intervention (week 12) baseline (week 0) and end of intervention (week 12)
Secondary lipid profile both groups were assessed fasting lipid profile (total cholesterol, triglyceride and HDL-cholesterol) at baseline (week 0) and end of intervention (week 12) baseline (week 0) and end of intervention (week 12)
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2