Durability of Addition of Roux-en-Y Gastric Bypass to Lifestyle Intervention and Medical Management in Achieving Primary Treatment Goals for Uncontrolled Type 2 Diabetes in Mild to Moderate Obesity: A Randomized Control Trial

Abstract Background There is high prevalence of prediabetes and type 2 diabetes mellitus (T2DM) in Saudi Arabia that is still increasing. Early diagnosis of prediabetes, and immediate, effective intervention is yet unestablished. Conventional health promotion approaches are used to educate prediabetic patients. Behavior modification is very effective in prediabetics to delay T2DM. Thus, the main objective of this study is to examine the effect of the new behavioral model, the Transtheoretical Model short messages (text 4 change) to modify lifestyle to prevent or delay the onset of T2DM, through promotion of a healthy diet and increased physical activity, in impaired glucose tolerance patients. Another objective is to estimate the impact of this model on markers of cardiovascular and metabolic risks as T2DM is one of the modifiable risk factors to prevent cardiovascular diseases. Methods This is a randomized controlled trial. One thousand and sixteen, eligible Saudi adults will be recruited from the Heart Health Promotion study (HHP), which was conducted at the King Saud University from July 2013 to April 2014. These adults were at a higher risk of developing T2DM within 2–3 years. The research team’s database has a contact list and they will recruit individuals over 6–8 weeks. All participants will be randomized at a 1:1 ratio into two groups, receive group education about lifestyle modifications and written information about diet and physical activity. Text 4 change SMS texts will be sent only to the intervention group. All participants will be assessed at baseline, 6, 12, 18, 24, 30, and 36 months for behavioral change using a World Health Organization (WHO) STEPS questionnaire and for glycated hemoglobin, biochemical and anthropometric measurements using standard methods. Discussion This new approach for promoting the importance of behavior modification in prediabetics is expected to delay and/or prevent the development of T2DM in Saudi Arabia, subsequently reducing the risk of cardiovascular morbidity and mortality too. Results from this study will promote an innovative and high-tech way to decrease the burden of cardiovascular diseases in Saudi Arabia. Trial registration International Standard Randomized Control Trial, registration number ISRCTN10857643. Registered 4 June, 2018.

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Effectiveness of a colour coded HbA1c graphical record in improving diabetes control in people with type 2 diabetes: A randomized control trial

Diabetes Research and Clinical Practice ◽

10.1016/j.diabres.2011.11.001 ◽

2012 ◽

Vol 95 (2) ◽

pp. e41-e44 ◽

Cited By ~ 1

Author(s):

S.S.L. Wong ◽

C.J. Ng ◽

S.M. Liew ◽

N. Hussein

Keyword(s):

Type 2 Diabetes ◽

Randomized Control Trial ◽

Diabetes Control ◽

Randomized Control

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Obesity-related cardiovascular risk factors after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention

Acta Endocrinologica ◽

10.1530/eje-10-0514 ◽

2010 ◽

Vol 163 (5) ◽

pp. 735-745 ◽

Cited By ~ 122

Author(s):

D Hofsø ◽

N Nordstrand ◽

L K Johnson ◽

T I Karlsen ◽

H Hager ◽

...

Keyword(s):

Risk Factors ◽

Type 2 Diabetes ◽

Gastric Bypass ◽

Cardiovascular Risk ◽

Cardiovascular Risk Factors ◽

Lifestyle Intervention ◽

Bypass Surgery ◽

Gastric Bypass Surgery ◽

Surgery Group

ObjectiveWeight reduction improves several obesity-related health conditions. We aimed to compare the effect of bariatric surgery and comprehensive lifestyle intervention on type 2 diabetes and obesity-related cardiovascular risk factors.DesignOne-year controlled clinical trial (ClinicalTrials.gov identifier NCT00273104).MethodsMorbidly obese subjects (19–66 years, mean (s.d.) body mass index 45.1 kg/m2(5.6), 103 women) were treated with either Roux-en-Y gastric bypass surgery (n=80) or intensive lifestyle intervention at a rehabilitation centre (n=66). The dropout rate within both groups was 5%.ResultsAmong the 76 completers in the surgery group and the 63 completers in the lifestyle group, mean (s.d.) 1-year weight loss was 30% (8) and 8% (9) respectively. Beneficial effects on glucose metabolism, blood pressure, lipids and low-grade inflammation were observed in both groups. Remission rates of type 2 diabetes and hypertension were significantly higher in the surgery group than the lifestyle intervention group; 70 vs 33%,P=0.027, and 49 vs 23%,P=0.016. The improvements in glycaemic control and blood pressure were mediated by weight reduction. The surgery group experienced a significantly greater reduction in the prevalence of metabolic syndrome, albuminuria and electrocardiographic left ventricular hypertrophy than the lifestyle group. Gastrointestinal symptoms and symptomatic postprandial hypoglycaemia developed more frequently after gastric bypass surgery than after lifestyle intervention. There were no deaths.ConclusionsType 2 diabetes and obesity-related cardiovascular risk factors were improved after both treatment strategies. However, the improvements were greatest in those patients treated with gastric bypass surgery.

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