Lifestyle Modification Intervention in Pre-diabetic Subjects

PreDiabetes Clinical Trial

Official title:

Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03211182
• Other study ID #: 201110024
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2017
• Last updated: July 5, 2017
• Start date: March 7, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2017
• Source: Taipei Medical University
• Contact: Hung-Yi Chiou, PhD
• Phone: +88627361661
• Email: hychiou[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The lifestyle intervention program focusing on healthy dietary habit and exercise effectively prevents progression to diabetes. Thus, the purpose of this study was to assess the effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.

Description:

The study is a 2-parallel groups' randomized controlled trial. Participants with elevated fasting plasma glucose concentrations (FPG 100-125 mg/dl) or glycated hemoglobin (HbA1C 5.7-6.3%) are enrolled. All study subjects are randomized to receive a lifestyle intervention (intervention group) or regular prevention education (control group). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (3th months, 6th months and 12th months). All participants complete a structured questionnaire, including basic information, disease history, physical activity, food-frequency, stage of change, and social support situation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2018
• Est. primary completion date: March 18, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• 40 years old or over

• elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)

Exclusion Criteria:

• having received a diagnosis of diabetes or receiving treatment for diabetes in 3 years

• having a history of cardiovascular disease, stroke, liver disease, kidney disease, cardiopulmonary disease, malignancy or cancer and musculoskeletal impairment

• receiving corticosteroids, androgens, estrogen containing compounds

• who had dietary problem

• pregnant women

• who joined other health intervention study in one year.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• lifestyle modification intervention
healthy lifestyle education and individualized counseling by well-trained case manager. The main goals of the lifestyle intervention included regular moderate intensity physical activity 150 min per week or more, and dietary strategies which reduce the risk of developing diabetes. The dietary suggestion was modified by Dietary Approaches to Stop Hypertension (DASH) Diet. Participants with BMI>= 24 kg/m2 were encouraged to gradually lose weight at a rate of 0.5-1.0 kg per week until they achieved a BMI of 24 kg/m2.

Locations

Country	Name	City	State
Taiwan	YUANH	Kaohsiung	Lingya Dist
Taiwan	MMH	Taipei	Zhongshan Dist.
Taiwan	SKH	Taipei	Shilin Dist.
Taiwan	TMUH	Taipei	Sinyi District,

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood sugar	changes in fasting glucose and glycated hemoglobin	3 month, 6 month and 12-month follow up
Secondary	body weight	weight in kilograms	3 month, 6 month and 12-month follow up
Secondary	BMI	weight and height will be combined to report BMI in kg/m^2	3 month, 6 month and 12-month follow up
Secondary	Metabolic syndrome	defined as 3 or more of 5 components (ie, abdominal obesity, elevated blood pressure, elevated triglycerides, low high-density lipoprotein cholesterol, and dysglycemia)	3 month, 6 month and 12-month follow up