Journal of Diabetology

ORIGINAL ARTICLES
Year
: 2022  |  Volume : 13  |  Issue : 2  |  Page : 166--170

The reversal model for metabolic syndrome (RMMS) study: The rationale and design


Subhajyoti Ghosh1, Banshi Saboo2,  
1 Apollo Clinic, Dibrugarh, Assam, India
2 DiaCare Diabetes and Hormone Clinic, Ahmedabad, Gujarat, India

Correspondence Address:
Dr. Subhajyoti Ghosh
Apollo Clinic, Graham Bazaar, Dibrugarh, Assam
India

Abstract

Background: Recently, attention is paid on strategies and policies to halt or reverse the forecast type 2 diabetes mellitus (T2DM) epidemic across the globe and in India. Metabolic syndrome (MetS) predisposed us to T2DM along with cardiovascular disease (CVD). Our study aims to develop a reversal model for people with MetS through an education program under observation. This paper will describe the design of the reversal model for metabolic syndrome (RMMS) study along with intervention strategies. Materials and Methods: The RMMS study is a multi-center, parallel arm, quasi-experimental study. The study will be done in western (viz., Ahmedabad) and eastern (viz., Guwahati and Dibrugarh) parts compromising 707 patients from each part. The intervention arm will be part of the “observation cum self-management education program” for a period of 6 months. The non-intervention arm will be followed up to 6 months with routine care. The analysis for the outcome will be done at the end of 6 months. The primary outcome measures will be the reversal of MetS or the components of MetS. The piloting of the study has been done after the ethical clearance, and necessary changes are also done in a proforma. Conclusion: The RMMS is first of its kind among Indian population to study the effectiveness of the reversal model. The results will provide insights into changes in the prevalence of the components of MetS and hence can be used as primary prevention strategies for T2DM and CVD.



How to cite this article:
Ghosh S, Saboo B. The reversal model for metabolic syndrome (RMMS) study: The rationale and design.J Diabetol 2022;13:166-170


How to cite this URL:
Ghosh S, Saboo B. The reversal model for metabolic syndrome (RMMS) study: The rationale and design. J Diabetol [serial online] 2022 [cited 2022 Aug 10 ];13:166-170
Available from: https://www.journalofdiabetology.org/text.asp?2022/13/2/166/351759


Full Text



 Introduction



“For the first time, a non-infectious disease has been seen as posing as serious a global health threat as infectious epidemics such as HIV/AIDS.”[1] The non-infectious diseases such as obesity, diabetes, hypertension, and cardiovascular diseases (CVDs) are on the rise for the last few decades. Most of them can be associated with insulin resistance and hence metabolic syndrome (MetS). The most recent concept about reversal of diabetes with some modifications can be implemented for the reversal of MetS. The reversal model will be implemented through “observation cum self-management education program.”

 Background



The central obesity is often associated with risk factors such as impaired glucose metabolism, increased blood pressure, and dyslipidemia, which are linked to insulin resistance. A person with these risk factors is said to have MetS.[2],[3]

The most popularly used definition for the survey and healthcare plan is as follows[4]:

WHO 1999: Presence of insulin resistance or glucose >6.1 mmol/L (110 mg/dL), 2 h glucose >7.8 mmol (140 mg/dL) (required) along with any two or more of the following:

High-density lipoprotein (HDL) cholesterol <0.9 mmol/L (35 mg/dL) in men < 1.0 mmol/L (40 mg/dL) in women;

Triglycerides >1.7 mmol/L (150 mg/dL);

Waist/hip ratio >0.9 (men) or >0.85 (women) or body mass index >30 kg/m2;

Blood pressure >140/90 mmHg.

 Incidence and Prevalence of MetS



The prevalence of MetS varies widely within populations.[5] The MetS prevalence increases with aging and higher in lower socio-economic groups,[6],[7] along with ethnic differences.[8]

The incidence of obesity and T2DM is running in parallel to the incidence of MetS, which can be seen from NHNES data (during 1988–2010) and CDC-published data.[9] Similar observations can be sought from NFHS data since inception to till date in India. According to the global survey of 2015 among obesity patients in 195 countries, 604 million adults and 108 million children were obese, respectively.[10] The prevalence went from 1.1% to 3.85% from 1980 to 2015.

MetS precedes type 2 diabetes by several years; hence, people with MetS can be the target for primary prevention of T2DM. The concept of MetS can be a great public health importance along with healthcare professionals in addressing the health hazards with central obesity.

 Reversal Model



The Counterpoint study (Counteracting Pancreatic Inhibition by Triglyceride) aimed to induce negative calorie balance using a very low calorie diet—about one-quarter of an average person’s daily food intake.[11]

A low-calorie diet (900 kcal) had shown significant improvements in insulin sensitivity along with glycemic parameter.[12]

According to the study by Wing et al.,[13] significant improvements of HbA1c were observed at 1 year with intermittently delivered very low-calorie diet. The observed glycemic improvements were not maintained by 2 years, but the group with intermittent very low-calorie diet needs less medication in comparison to the group with LCD arm.

According to the Look AHEAD trial of 2003, in between the intervention group on intensive lifestyle (calorie restriction and increased physical activity) and a control group (diabetes support and education), the study revealed that 11.5% of the participants in the intervention group achieved remission (partial or complete) at the end of 1 year; the remission rates achieved in the intervention group were 3–6 times higher than those in the control group.[14]

The DiRECT study (cluster randomized trial) enrolled relatively healthy T2DM participants of around 306. They were randomized to either the intervention group (low-calorie meal replacement diet) or the control group (standard diabetes care). At 1 year, 46% met the criteria of diabetes remission and by 2 years it was 36%.[15]

In the Reversal Intervention for Metabolic Syndrome (TRIMS) study, a mixed-ethnic population with MetS was randomized into either intervention or control arm. The data will be collected at 6 and 12 months of follow-up. The primary outcome measure was reversal of MetS in either of the groups at the end of 12 months.[16]

Therefore, research is needed among MetS population regarding the efficacy of lifestyle interventions reversal and hence prevention of T2DM. The RMMS study will be done to evaluate the effectiveness of “reversal model for metabolic syndrome” among the populations with MetS. The paper highlights the developmental design of the RMMS study, which includes the framework used in delivering the trial. The study will be done with the objective to evaluate the effectiveness of “reversal model for metabolic syndrome.”

Research methodology

The present study will be multi-centric to evaluate the difference of attributes in MetS comparing eastern with western counterpart of India, thereby studying the outcome of reversal model among the metabolic subjects of the study after a period of intervention.

Study site and description: This is a multi-center study.

Eastern India: Dibrugarh and Guwahati

Western India: Ahmadabad

Sample size determination: As the study is estimating the difference between two study populations, the sample size would be calculated from the below mentioned formula with stated specified absolute precision as:

Prevalence of MetS in Dibrugarh: P1[17]

Prevalence of MetS in Ahmedabad: P2[18]

Absolute precision required on either side of true values of the difference between the population prevalence (in percentage) is:

Confidence level: 100 (1-α)%;

Intermediate value, V= P1 (1-P1) + P2 (1-P2).

Therefore, Ƞ = Z21-α/2 (V/d2).

The value of P1 is 32.87%, P2 41.01%, d = 5%, CI = 95%.

The sample size is calculated to be 707 in each center.

Sampling technique

Multistage sampling technique

It consists of two or more stages of random sampling. A different type of cluster is randomly sampled at each stage, with the clusters nested within each other at successive stages. The final stage of sampling involves choosing a random sample from the selected clusters at the penultimate stage. The strata selected in the study are based on geographical regions considering socio-economic status to have samples from almost all the socio-economic status.[19]

Research design

The study would be a multi-center, parallel-arm, quasi-experimental study that analyzed the outcome of the reversal model.

Initially, after sampling, three geographical locations are chosen for the study, viz., Ahmedabad representing the western part and Guwahati and Dibrugarh representing the eastern part. The population is diverse in both parts due to ethnic diversities within our population; hence we used socio-economic classification for stratification of the study population. Then the population was divided among high, middle, and lower classes in each of the centers. Finally, the equivalent sample was collected for each socio-economic class in each study center. Then a random sample will be chosen to collect the epidemiological data which include general demographic data, anthropometric data, physical activity data, mental stress data, and substance abuse data along with blood samples for biochemical analysis. Diet history is also included in the proforma. Then the data will be assessed for prevalence of MetS and the number of attributes within the study population. Then the person with MetS will be invited for the study. After obtaining the informed consent, the participants will be randomized into two groups: intervention group and control group. Both groups will be followed up to 6 months to assess the outcome as shown in [Figure 1].{Figure 1}

Study procedure and technique

Those participants having the component of MetS will be randomized into two groups after obtaining informed consent. The initial epidemiological data will be considered as baseline data for each participant. The participants in the intervention group will be put into the reversal model called “observation cum self-management education program.” The control group will be only observed over 6 months. The participants in each group will be assessed routinely at the 3rd month and at the end of the study (6th month). Finally, the data will be assessed to analyze the outcome and feasibility of the RMMS in the community, as shown in [Figure 2].{Figure 2}

The model will be delivered through a “self-management education program” that encourages changing the lifestyle of individuals with MetS. The key behavioral goals the program aimed to promote include:

Increasing physical activity, ≥ 45 min of moderate-intensity activity (or an extra 4500 steps) per day;

Losing weight (reducing waist size), a reduction of between 5% and 10% of initial body weight through increasing physical activity and/or reducing calorie intake;

Increasing dietary fiber consumption, particularly wholegrain, legumes, fruits, and vegetables;

Reducing consumption of saturated fats and salt;

Tobacco and smoking cessation;

Reducing and/or abstinence from alcohol.

Diet modification

The diet history will be collected through FFQ (Food Frequency Questionnaire) for the last 1 week (to minimize the recall bias). This FFQ will be analyzed to assess the average consumption in the week; it will be converted to total calorie consumption for the week. Then per day calorie consumption will be calculated. About 500–600 calorie deficit diet plan will be prescribed for the interventional group.

The other plan advised will be substitution of policed rice or wheat with parboiled or brown rice and wheat, increasing the quantity and quality of vegetable with every meal, abstinence from sweet, sweeteners and juice.

Physical activity

The history regarding physical activity will be collected through GPAQ of the last 1 week (to minimize the recall bias). This GPAQ will be analyzed to assess the MET equivalent for the week. Then per day MET equivalent will be calculated. Then participant in the intervention group will be encouraged to increase their MET equivalent per day through engaging in various modes of physical activities. It will follow FITT principle (Frequency, 5–6 days per week; Intensity, moderate-to-severe intensity; Type, strength, aerobics, flexibility, and endurance exercise; and Timing, morning is ideal).

Period of study: One year.

Study population: Adult population (18–59 years).

Exclusion criteria

Subjects residing within the study area who are not willing to participate in the study.

All the pregnant women residing in the study area.

Subjects residing within the study area suffering from severe complications.

The study definition used is the WHO 1999 criteria for the MetS.

Expected outcome

Primary outcome: Reversal of MetS according to the WHO criteria in the intervention group compared with the control group, after 6 months of follow-up.

Secondary outcome: Individual components of the MetS (fasting plasma glucose, triglycerides, HDL cholesterol, blood pressure, waist circumference) and 2-h glucose.

Data collection and assessment of outcome

Proforma incorporating data regarding socio-demographic profile, family history, substance abuse history;

Proforma regarding the quality of life, mental health;

Diet proforma and physical activity proforma;

Anthropometry proforma.

Clinical measurements and laboratory procedure

Weight and height and related parameters;

Waist circumference and hip circumference and related parameters;

Blood pressure;

Biochemical tests: Hb%, fasting blood sugar, post-prandial blood sugar, HbA1c, fasting lipid profile, thyroid-stimulating hormone, serum creatinine, Homeostatic Model Assessment for Insulin Resistance, and serum C-peptide.

Data analysis

SPSS;

Appropriate test of significance as applicable.

The technique of follow-up is as follows:

Telephonic consultation;

Physical visit at the start of the intervention, at the 3rd month, and at the end of the study.

 Conclusion



The RMMS is first of its kind among Indian population to study the effectiveness of the reversal model; if the study is effective, then the model can be implemented as primary prevention for diabetes and CVDs.

Ethical clearance

The ethical clearance was obtained from the Ethics Committee, Institute of Neurological Sciences situated at Guwahati, Assam, India prior to initiation of the study.

Acknowledgement

None.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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