Glycemic control with Low Glycemic Index preparations of Kerala cuisine in subjects with Type 2 Diabetes.

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2019/12/022425

Lead Sponsor: Amrita Institute of Medical Sciences and Research Centre

Brief Summary: The burden of Diabetes is on the rise across the globe and the rising prevalence of type 2 diabetes, particularly in developing countries appears to be mainly related to the increasing number of overweight and obese individuals all over the world. In Asians the prevalence of diabetes at any body mass index (BMI), waist circumference and waistâ€“toâ€“hip ratio (WHR) is higher compared to the western population.Central (truncal) obesity has been found to associate more strongly with insulin resistance and with diabetes than generalized obesity. Diabetes and obesity have emerged as a major public health problem and are increasing in rural and urban regions of India particularly Kerala. The prevalence of obesity among people with diabetes in South Kerala is 66%.

Recently, the consumption of low GI ingredients of Kerala cuisine such as red rice and whole grains are being replaced with white rice and commercially available wheat flour. The effect on the consumption of locally available low glycemic index cereals of Kerala cusine on glycemic control and body composition using DXA has not been examined previously. Several studies have used dual energy X-ray absorptiometry (DXA) to study fatness and fat distribution in persons with type 2 diabetes mellitus (T2DM) compared with healthy controls, but none have reported the changes in body composition with LGI recipes of Kerala cuisine. Therefore, the purpose of this study was to investigate the effect of a 24-week intervention with low GI diet of Kerala cuisine on body composition, particularly truncal fat using DXA in people with type 2 diabetes mellitus. We hypothesized that an intervention of low GI diet using locally available ingredients of Kerala cuisine in South Indians would significantly decrease the fat mass especially truncal fat mass values and would bring about improvements in glycemic control and cardiometabolic variables .

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Stable on medications (OHA and insulin) for 3 months.
Duration of diabetes for atleast 1 year.

Exclusion Criteria

Pregnant women.
Gastrointestinal complications.
With metal implants.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in HbA1c	6 months

Secondary Outcome Measures

Name	Time	Method
Reduction in truncal fat mass and increase in lean body mass.	Reduction cardiometabolic variables.

Trial Locations

Locations (1): Amrita Institute of Medical Sciences and Research Centre
🇮🇳
Ernakulam, KERALA, India
Amrita Institute of Medical Sciences and Research Centre
🇮🇳Ernakulam, KERALA, India
Nivedita Pavithran
Principal investigator
7034028176
brinivedita@aims.amrita.edu