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AIM To determine the short-term biochemical effects and clinical tolerability of intermittent fasting(IF) in adults with type 2 diabetes mellitus(T2DM).METHODS We describe a three-phase observational study(baseline 2 wk, intervention 2 wk, follow-up 2 wk) designed to determine the clinical, biochemical, and tolerability of IF in community-dwelling volunteer adults with T2DM. Biochemical, anthropometric, and physical activity measurements(using the Yale Physical Activity Survey) were taken at the end of each phase. Participants reported morning, afternoon and evening self-monitored blood glucose(SMBG) and fasting duration on a daily basis throughout all study stages, in addition to completing a remote food photography diary three times within each study phase. Fasting blood samples were collected on the final days of each study phase. RESULTS At baseline, the ten participants had a confirmed diagnosis of T2DM and were all taking metformin, and on average were obese [mean body mass index(BMI) 36.90 kg/m~2]. We report here that a short-term periodof IF in a small group of individuals with T2DM led to significant group decreases in weight(-1.395 kg, P = 0.009), BMI(-0.517, P = 0.013), and at-target morning glucose(SMBG). Although not a study requirement, all participants preferentially chose eating hours starting in the midafternoon. There was a significant increase(P < 0.001) in daily hours fasted in the IF phase(+5.22 h), although few attained the 18-20 h fasting goal(mean 16.82 ± 1.18). The increased fasting duration improved at-goal(< 7.0 mmol/L) morning SMBG to 34.1%, from a baseline of 13.8%. Ordinal Logistic Regression models revealed a positive relationship between the increase in hours fasted and fasting glucose reaching target values(χ~2 likelihood ratio = 8.36, P = 0.004) but not for afternoon or evening SMBG(all P > 0.1). Postprandial SMBGs were also improved during the IF phase, with 60.5% readings below 9.05 mmol/L, compared to 52.6% at baseline, and with less glucose variation. Neither insulin resistance(HOMAIR), nor inflammatory markers(C-reactive protein) normalized during the IF phase. IF led to an overall spontaneous decrease in caloric intake as measured by food photography(Remote Food Photography Method). The data demonstrated discernable trends during IF for lower energy, carbohydrate, and fat intake when compared to baseline. Physical activity, collected by a standardized measurement tool(Yale Physical Activity Survey), increased during the intervention phase and subsequently decreased in the follow-up phase. IF was well tolerated in the majority of individuals with 6/10 participants stating they would continue with the IF regimen after the completion of the study, in a full or modified capacity(i.e., every other day or reduced fasting hours).CONCLUSION The results from this pilot study indicate that shortterm daily IF may be a safe, tolerable, dietary intervention in T2DM patients that may improve key outcomes including body weight, fasting glucose and postprandial variability. These findings should be viewed as exploratory, and a larger, longer study is necessary to corroborate these findings.
AIM To determine the short-term biochemical effects and clinical tolerability of intermittent fasting (IF) in adults with type 2 diabetes mellitus (T2DM). METHODS We describe a three-phase observational study (baseline 2 wk, intervention 2 wk, follow-up 2 wk) designed to determine the clinical, biochemical, and tolerability of IF in community-dwelling volunteer adults with T2DM. Biochemical, anthropometric, and physical activity measurements (using the Yale Physical Activity Survey) were taken at the end of each phase. Participants reported morning, afternoon and evening self-monitored blood glucose (SMBG) and fasting duration on in a daily basis throughout all study stages, in addition to completing remote photography plus three times within each study phase. Fasting blood samples were collected on the final days of each study phase. RESULTS At baseline, the ten participants had a confirmed diagnosis of T2DM and were all taking metformin, and on average were obese [mean body mass index (BMI 36.90 kg / m 2). We reported here that a short-term period of IF in a small group of individuals with T2DM led to significant group decreases in weight (-1.395 kg, P = 0.009), BMI (-0.517 , There was a significant increase (P <0.001) in daily hours fasted in the IF (+5.22 h), although few attained the 18-20 h fasting goal (mean 16.82 ± 1.18). The increased fasting duration improved at-goal (<7.0 mmol / L) morning SMBG to 34.1% from a baseline of 13.8 %. Ordinal Logistic Regression models revealed a positive relationship between the increase in hours fasted and fasting glucose reaching target values (χ ~ 2 likelihood ratio = 8.36, P = 0.004) but not for afternoon or evening SMBG (all P> 0.1). Postprandial SMBGs were also improved during the IF phase, with 60.5% readings below 9.05 mmol / L, compared to 52.6% at baseline, and wit hless glucose variation. Neither insulin resistance (HOMAIR), nor inflammatory markers (C-reactive protein) normalized during the IF phase. IF led to an overall spontaneous decrease in caloric intake as measured by food photography (Remote Food Photography Method). The data demonstrated that discernable trends during IF for lower energy, carbohydrate, and fat intake when compared to baseline. Physical activity, collected by a standardized measurement tool (Yale Physical Activity Survey), increased during the intervention phase and subsequently decreased in the follow-up phase. IF was well tolerated in the majority of individuals with 6/10 participants stating they would continue with the IF regimen after the completion of the study, in a full or modified capacity (ie, every other day or reduced fasting hours) .CONCLUSION The results from this pilot study indicate that shortterm daily IF may be a safe, tolerable, dietary intervention in T2DM patients that may improve key outcomes including body w eight, fasting glucose and postprandial variability. These findings should be viewed as exploratory, and a larger, longer study is necessary to corroborate these findings.