Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial

Abstract

Background: Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk. Methods: Randomized Clinical Trial (RCT) to compare the impact of FI and II on IR and pancreatic β-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015-2016 and analyzed in 2017-2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic β-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months. Results: FI group improved area under the glucose curve (AUC) (from 18,597 ± 2611 to 17,237 ± 2792, p = 0.004) and the Matsuda index (from 3.5 ± 2.3 to 4.7 ± 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 ± 0.4 to 1.9 ± 0.73, p < .0001) at 12 months. The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% Vs II 60%). Conclusions: FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased. Trial registration: This study was retrospectively registered at clinicaltrials.gov on December 15, 2015 (NTC026365646).

Effect of linagliptin on glucose metabolism and pancreatic beta cell function in patients with persistent prediabetes after metformin and lifestyle

“…We reported an improvement in glucose levels as well as in islet function in patients at high risk for developing T2D with the combination of linagliptin, metformin and lifestyle 39 . To our knowledge this is the first study to evaluate the additive effect of a DPP-IV inhibitor in patients with prediabetes previously treated with metformin and lifestyle and persistent impaired glucose tolerance 32 .…”

“…Lifestyle programs have beneficial effects in weight control and glucose metabolism by improving insulin sensitivity, mainly in skeletal muscle, while metformin improves insulin sensitivity in liver, reducing hepatic gluconeogenesis, which could be beneficial mainly in subjects with impaired fasting glucose 30 – 32 . However, in patients with IGT insulin resistance occurs predominantly at the muscle level and have a more marked pancreatic β- and alpha-cell dysfunction together with a reduction in the incretin effect, requiring different interventions to improve glucose metabolism 16 , 53 , 54 .…”

“…The RESCATHEME project ( Resc ue A fter The rapy with Me tformin) was a 6 month single center double-blind randomized clinical trial performed in patients with IGT who did not achieve normal glucose tolerance after one year of treatment with metformin and lifestyle modifications. Patients were recruited from a previous diabetes prevention study, performed at the Metabolic Research Laboratory in the University of Guanajuato, México, which evaluated the effect of metformin plus lifestyle modifications on T2D prevention for 12 months in patients with prediabetes 32 .…”

“…In fact, restoration of normoglycemia should be the main goal of any preventive strategy in T2D 28 , 29 . Different approaches have been employed to delay or prevent T2D, including lifestyle modification and pharmacotherapy mainly based on metformin 27 , 30 – 32 . However, lifestyle changes were insufficient to prevent T2D in ˃50% of cases due mainly to lack of adherence.…”

Prevalence of Diabetes and Impaired Fasting Glycemia in Patients With Oral Cancer: A Retrospective Study in Hungary

“…Unfortunately, there is an increasing trend in the number of patients living with diabetes (3). Most patients have T2D, which is preventable with a healthy lifestyle (4). In 2017, 451 million people were living with DM worldwide.…”