A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns in Obese Type 2 Diabetes Emirati Patients: a Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644134
• Other study ID #: RashidCDR
• Secondary ID: University of Sh
• Status: Completed
• Phase: N/A
• Start date: September 26, 2013
• Est. completion date: July 14, 2015

Study information

• Verified date: August 2018
• Source: Rashid Centre for Diabetes and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Globally, type 2 diabetes mellitus (DM) and obesity are considered to be the fastest growing disorders and their prevalence has increased dramatically over the last twenty years.

Recent studies have shown that about 19% of UAE population has been diagnosed with DM and 57% of Emirati patients with type 2 DM are obese.

Optimal glycemic control and weight management involve comprehensive lifestyle approaches including nutrition recommendations and adequate levels of physical activity.

However, recent views have suggested that there are other factors, such as sleep deprivation and stress, contribute to development of type 2 DM.

Taking into account the previous findings, the present study was designed to investigate the effects of a personalized intervention on weight and glycemic control in Emirati patients with type 2 DM. The intervention involves assessment and modification of sleep patterns and stress levels.

Description:

The present study is a randomized controlled trial which was conducted at Rashid Centre for Diabetes and Research (RCDR) in Ajman which in one of the seven Emirates of the United Arab Emirates (UAE). The study was approved by the research ethics committee of Al Qassimi Clinical Research Centre, Al Qassimi Hospital (Ministry of Health, UAE).

The study population is comprised of Emirati individuals (n = 51) who attending RCDR diabetes clinics in a quarterly basis (an initial visit and three follow-up visits per annum). The participants were recruited from RCDR diabetes clinics and through different methods including (i) direct contact (ii) distribution of informative flyers and (iii) phone calls using Diamond, an electronic medical database of RCDR patients. The screening process involved 110 Emirati patients with T2DM and 51 individuals were eligible to participate in the present trial based on the following inclusion and exclusion criteria. The inclusion criteria were (i) Age between 18-60 years (ii) Body Mass Index (BMI > 25 Kg/m2) and (iii) T2DM. The exclusion criteria were (i) Age < 18 and > 60 years (ii) BMI < 25 Kg/m2) (iii) type 1 DM (iv) diagnosis of atrial fibrillation and/or atrial flutter and/or bundle branch block and (v) heart transplantation.

The eligible participants were randomly allocated into an intervention group (n = 26) and or into a control group (n = 25). Non-compliance was the main obstacle to maintain the same number of the randomized participants in each group and 19% and 24 % of the participants in the intervention and control group, respectively, did not attend the first visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 14, 2015
• Est. primary completion date: June 5, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age between 18-60 years

• Body Mass Index (BMI > 25 Kg/m2)

• T2DM

Exclusion Criteria:

• Age < 18 and > 60 years

• BMI < 25 Kg/m2)

• Type 1 DM

• Diagnosis of atrial fibrillation and/or atrial flutter and/or bundle branch block heart transplantation

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Assessment of physiological stress and sleep pattern
The personalized intervention consists of (i) information session (ii) pre-assessment (first assessment) of stress and recovery levels, and sleep patterns (iii) individual feedback sessions and action plans based on the outcomes of the initial assessment (iv) monitoring and follow-ups (v) post-assessment (second assessment) of stress and recovery levels and sleep patterns.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rashid Centre for Diabetes and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Measurement of body weight at the site visit pre/post the intervention	6 months
Primary	Change in BMI	Measurement of BMI at the site visit pre/post the intervention	6 months
Primary	Change in HbA1c	Measurement of HbA1c at the site visit pre/post the intervention	6 month