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Diabetes Therapy : Research, Treatment... Aug 2023Time in range (TIR) as assessed by continuous glucose monitoring (CGM) measures an individual's glucose fluctuations within set limits in a time period and is...
INTRODUCTION
Time in range (TIR) as assessed by continuous glucose monitoring (CGM) measures an individual's glucose fluctuations within set limits in a time period and is increasingly used together with HbA1c in patients with diabetes. HbA1c indicates the average glucose concentration but provides no information on glucose fluctuation. However, before CGM becomes available for patients with type 2 diabetes (T2D) worldwide, especially in developing nations, fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) are still the common biomarkers used for monitoring diabetes conditions. We investigated the importance of FPG and PPG to glucose fluctuation in patients with T2D. We used machine learning to provide a new estimate of TIR based on the HbA1c, together with FPG and PPG.
METHODS
This study included 399 patients with T2D. (1) Univariate and (2) multivariate linear regression models and (3) random forest regression models were developed to predict the TIR. Subgroup analysis was performed in the newly diagnosed T2D population to explore and optimize the prediction model for patients with different disease history.
RESULTS
Regression analysis suggests that FPG was strongly linked to minimum glucose, while PPG was strongly correlated with maximum glucose. After FPG and PPG were incorporated into the multivariate linear regression model, the prediction performance of TIR was improved compared with the univariate correlation between HbA1c and TIR, and the correlation coefficient (95% CI) increased from 0.62 (0.59, 0.65) to 0.73 (0.72, 0.75) (p < 0.001). The random forest model significantly outperformed the linear model (p < 0.001) in predicting TIR through FPG, PPG and HbA1c, with a stronger correlation coefficient 0.79 (0.79, 0.80).
CONCLUSIONS
The results offered a comprehensive understanding of glucose fluctuations through FPG and PPG compared to HbA1c alone. Our novel TIR prediction model based on random forest regression with FPG, PPG, and HbA1c provides a better prediction performance than the univariate model with solely HbA1c. The results indicate a nonlinear relationship between TIR and glycaemic parameters. Our results suggest that machine learning may have the potential to be used in developing better models for understanding patients' disease status and providing necessary interventions for glycaemic control.
PubMed: 37328714
DOI: 10.1007/s13300-023-01432-2 -
Nutrients Jun 2024Nutritional bars (NBs) are gaining popularity among healthy and athletic individuals, but postprandial antioxidative response has not been investigated. Therefore, the...
Nutritional bars (NBs) are gaining popularity among healthy and athletic individuals, but postprandial antioxidative response has not been investigated. Therefore, the current study examined the postprandial alterations in total phenolic content (TPC), total antioxidant capacity (T-AOC), malondialdehyde (MDA), and Superoxide dismutase (SOD) in the plasma of healthy individuals after the ingestion of 140 g (510 Kcal) from formulated date-based bars (DBBs) or fruit-based bars (FBBs). Firstly, the free and bound phenolic contents (PCs) were determined to be 10.15 and 12.98 and 6.19 and 3.57 mg GAE g, respectively. FBBs were significantly higher in free PC than DBBs, while DBBs were considerably higher in bound PC than FBBs. Secondly, twenty participants with age, height, weight, body mass index (BMI), fat mass, and fat-free mass averages of 21.4 years, 170.0 cm, 66.3 kg, 22.9 kg m, 14.5, and 29.2 kg, respectively, were subjected to metabolic experiments (ISRCTN19386758). Ingestion of 140 g of FBB or DBB resulted in 288.50 or 302.14 µg TPC mL blood, respectively. Postprandial TPC content increased with time progression and peaked after 120 min. T-AOC contents averaged 22.63 and 23.61 U mL before ingestion of FBBs or DBBs, respectively. The T-AOC content increased significantly 120 and 180 min after ingestion of DBBs, while no significant change was noted after consuming FBBs. A significant decrease in MDA content was observed 180 min after consuming DBBs, while no significant change was noted after consuming FBBs. SOD concentrations ranged from 193.99 to 201.07 U L in FBBs and DBBs, respectively. No considerable response was noted up to 3 h after ingestion of FBBs. On the contrary, a significant response was found 120 min after consuming DBBs. Pearson's correlation coefficient indicated a highly significant positive correlation coefficient ( < 0.01) between T-AOC and either MDA or SOD, as well as between MDA and SOD. The principal component analysis demonstrated a strong and positive relationship between SOD and TPC at 60 and 120 min after DBB ingestion. In conclusion, the relative changes in postprandial responses in T-AOC and MDA did not significantly ( > 0.05) differ between DBBs and FBBs, except for TPC ( = 0.04, paired -test) and SOD ( = 0.003, paired -test). Further studies with an extended experimental time are needed to confirm the current findings.
Topics: Humans; Postprandial Period; Antioxidants; Fruit; Male; Young Adult; Malondialdehyde; Female; Superoxide Dismutase; Adult; Phenols; Food, Formulated; Healthy Volunteers
PubMed: 38892726
DOI: 10.3390/nu16111794 -
Physiological Reports Feb 2024Muscle inactivity may reduce basal and postprandial muscle protein synthesis (MPS) rates in humans. Anti-inflammatory treatment alleviates the MPS impairments in younger...
Muscle inactivity may reduce basal and postprandial muscle protein synthesis (MPS) rates in humans. Anti-inflammatory treatment alleviates the MPS impairments in younger individuals. The present study explored the influence of nonsteroidal anti-inflammatory drugs (NSAIDs) upon MPS during a period of inactivity in older humans. Eighteen men (age 60-80 years) were allocated to ibuprofen (1200 mg/day, Ibu) or control (Plc) groups. One lower limb was cast immobilized for 2 weeks. Postabsorptive and postprandial MPS was measured before and after the immobilization by L-[ring- C ]-phenylalanine infusion. The protein expression of select anabolic signaling molecules was investigated by western blot. Basal (0.038 ± 0.002%/h and 0.039 ± 0.005%/h, Plc and Ibu, respectively) and postprandial (0.064 ± 0.004%/h and 0.067 ± 0.010%/h, Plc and Ibu, respectively) MPS rate were higher pre-immobilization compared to basal (0.019 ± 0.005%/h and 0.020 ± 0.010%/h, Plc and Ibu, respectively) and postprandial (0.033 ± 0.005%/h and 0.037 ± 0.006%/h, Plc and Ibu, respectively) MPS rate post-immobilization (p < 0.001). NSAID treatment did not affect the suppression of MPS (p > 0.05). The anabolic signaling were in general reduced after immobilization (p < 0.05). These changes were unaffected by NSAID treatment (p > 0.05). Basal and postprandial MPS dropped markedly after 2 weeks of lower limb immobilization. NSAID treatment neither influenced the reduction in MPS nor the anabolic signaling after immobilization in healthy older individuals.
Topics: Male; Humans; Aged; Middle Aged; Aged, 80 and over; Muscle Proteins; Leg; Myofibrils; Lower Extremity; Anti-Inflammatory Agents, Non-Steroidal; Quadriceps Muscle; Muscle, Skeletal; Postprandial Period
PubMed: 38406891
DOI: 10.14814/phy2.15958 -
Food Research International (Ottawa,... Jul 2024Slowing the rate of carbohydrate digestion leads to low postprandial glucose and insulin responses, which are associated with reduced risk of type 2 diabetes. There is... (Randomized Controlled Trial)
Randomized Controlled Trial
Impact of chickpea hummus on postprandial blood glucose, insulin and gut hormones in healthy humans combined with mechanistic studies of food structure, rheology and digestion kinetics.
Slowing the rate of carbohydrate digestion leads to low postprandial glucose and insulin responses, which are associated with reduced risk of type 2 diabetes. There is increasing evidence that food structure plays a crucial role in influencing the bioaccessibility and digestion kinetics of macronutrients. The aims of this study were to compare the effects of two hummus meals, with different degrees of cell wall integrity, on postprandial metabolic responses in relation to the microstructural and rheological characteristics of the meals. A randomised crossover trial in 15 healthy participants was designed to compare the acute effect of 27 g of starch, provided as hummus made from either intact chickpea cells (ICC) or ruptured chickpea cells (RCC), on postprandial metabolic responses. In vitro starch digestibility, microstructural and rheological experiments were also conducted to evaluate differences between the two chickpea hummus meals. Blood insulin and GIP concentrations were significantly lower (P < 0.02, P < 0.03) after the consumption of the ICC meal than the meal containing RCC. In vitro starch digestion for 90 min was slower in ICC than in RCC. Microscopic examination of hummus samples digested in vitro for 90 min revealed more intact chickpea cells in ICC compared to the RCC sample. Rheological experiments showed that fracture for ICC hummus samples occurred at smaller strains compared to RCC samples. However, the storage modulus for ICC was higher than RCC, which may be explained by the presence of intact cells in ICC. Food structure can affect the rate and extent of starch bioaccessibility and digestion and may explain the difference in the time course of metabolic responses between meals. The rheological properties were measured on the two types of meals before ingestion, showing significant differences that may point to different breakdown mechanisms during subsequent digestion. This trial was registered at clinicaltrial.gov as NCT03424187.
Topics: Humans; Cicer; Postprandial Period; Insulin; Blood Glucose; Digestion; Cross-Over Studies; Rheology; Adult; Male; Female; Young Adult; Starch; Gastric Inhibitory Polypeptide; Healthy Volunteers; Kinetics
PubMed: 38823849
DOI: 10.1016/j.foodres.2024.114517 -
Journal of Diabetes Investigation Feb 2024To explore the relationship between mealtime delays of up to 3 h and subsequent glucose fluctuations, healthy young adults were allocated to three delayed dinnertimes... (Randomized Controlled Trial)
Randomized Controlled Trial
To explore the relationship between mealtime delays of up to 3 h and subsequent glucose fluctuations, healthy young adults were allocated to three delayed dinnertimes in randomized order. Participants consumed test meals for lunch and dinner. After assessing the glucose responses using intermittently scanned continuous glucose monitoring devices (isCGM), the peak glucose elevation, and incremental area under the curve (iAUC) of postprandial glucose during certain intervals increased significantly when the time between lunch and dinner was delayed by 1 h or more. Our results support the importance of improving irregular mealtime habits, such as late eating.
Topics: Humans; Young Adult; Blood Glucose; Blood Glucose Self-Monitoring; Glucose; Meals; Postprandial Period; Cross-Over Studies; Insulin
PubMed: 37920117
DOI: 10.1111/jdi.14104 -
European Review For Medical and... Dec 2023This study aims to identify the characteristics of Egyptian patients suffering from type 2 diabetes mellitus (T2DM), determine disease control rates, and gain insights...
OBJECTIVE
This study aims to identify the characteristics of Egyptian patients suffering from type 2 diabetes mellitus (T2DM), determine disease control rates, and gain insights into clinical treatments.
PATIENTS AND METHODS
A total of 2,516 patients with T2DM were recruited from 244 private clinics across Egypt in a one-month period from May to June 2017. Data collected from patients included glycemic control parameters of glycosylated hemoglobin, fasting plasma glucose, and postprandial glucose. Additional information gathered included patients' weight, age, level of physical activity, smoking habits, presence of comorbidities, type of treatment received for type 2 diabetes, number and severity of hypoglycemic events, as well as treatment modification by the physician in the last visit. The type of statistics used for the analysis is descriptive statistics and regression model.
RESULTS
Only 18.4% of participating patients achieved the target level of glycosylated hemoglobin of 7% or below. The mean age of these patients was 54±11.2 years, and the mean duration since the first diagnosis was 6.6±6.4 years. A total of 33.4% of all patients had no known comorbidity, while the rest had one or more known and treated comorbidities. A total of 76% of patients received sulfonylurea either as monotherapy or in combination with other treatments. In addition, no treatment modifications or adjustments were provided for 32% of the study participants who did not reach their glycemic control target.
CONCLUSIONS
In Egypt, there is a low rate of glycemic control among private patients and a high prevalence of comorbid conditions. This is likely to cause a significant health burden to people with T2DM, the healthcare system, and the economy due to a loss in productivity. This study presented an argument for better-managed measures to improve glycemic control in the population, such as patient education to increase patient awareness and adherence to treatment protocols as well as improved adherence to guidelines by clinicians.
Topics: Humans; Adult; Middle Aged; Aged; Diabetes Mellitus, Type 2; Egypt; Glycated Hemoglobin; Blood Glucose; Hypoglycemic Agents
PubMed: 38095390
DOI: 10.26355/eurrev_202312_34581 -
Diabetes Technology & Therapeutics Apr 2024The Closing the Loop in Adults With Type 1 Diabetes (CLEAR) randomized crossover study compared a novel fully closed-loop insulin delivery system with no carbohydrate... (Randomized Controlled Trial)
Randomized Controlled Trial
The Closing the Loop in Adults With Type 1 Diabetes (CLEAR) randomized crossover study compared a novel fully closed-loop insulin delivery system with no carbohydrate entry or mealtime bolusing (CamAPS HX), with standard insulin pump therapy and glucose sensor in adults with type 1 diabetes and suboptimal glycemic outcomes. This qualitative substudy aimed to understand the psychosocial impact of using the fully automated system. Adults participating in the CLEAR study were invited to take part in a virtual semistructured interview after they had completed 8 weeks using the fully closed-loop system. Recruitment continued until there was adequate representation and data saturation occurred. Interviews were anonymized and transcribed for in-depth thematic analysis using an inductive-deductive approach. Study participants were also asked to complete questionnaires assessing diabetes distress, hypoglycemia confidence, and closed-loop treatment satisfaction. Eleven participants (eight male and three female; age range 26-66 years) were interviewed. After an initial adjustment period, interviewees reported enjoying a reduction in diabetes burden, freed-up mental capacity, and improved mood. All were happy with overnight glycemic outcomes, with the majority reporting benefits on sleep. Although experiences of postprandial glucose outcomes varied, all found mealtimes easier and less stressful, particularly when eating out. Negatives raised by participants predominantly related to the insulin pump hardware, but some also reported increased snacking and challenges around resuming carbohydrate counting at trial closeout. In adults with type 1 diabetes, use of a fully closed-loop insulin delivery system had significant quality-of-life benefits and provided a welcome break from the day-to-day demands of living with diabetes. NCT04977908.
Topics: Adult; Male; Humans; Female; Middle Aged; Aged; Insulin; Diabetes Mellitus, Type 1; Blood Glucose; Hypoglycemic Agents; Cross-Over Studies; Treatment Outcome; Insulin Infusion Systems; Insulin, Regular, Human
PubMed: 38426909
DOI: 10.1089/dia.2023.0394 -
The British Journal of Nutrition Jul 2023Goat milk yogurt (GMY) and raisins are popular foods with a favourable nutrient profile. Our aim was to determine the glycaemic index (GI) and postprandial responses to... (Randomized Controlled Trial)
Randomized Controlled Trial
Short-term effects of goat milk yogurt-containing angiotensin-converting enzyme inhibitory peptides and two raisin varieties on subjective appetite, blood pressure and glycaemic responses in healthy adults. Results from a randomised clinical trial.
Goat milk yogurt (GMY) and raisins are popular foods with a favourable nutrient profile. Our aim was to determine the glycaemic index (GI) and postprandial responses to GMY-containing angiotensin-converting enzyme inhibitory (ACE-I) peptides carrying the RPKHPINHQ isracidin fragment and two Greek raisin varieties in an acute feeding setting. A total of twelve healthy participants (four male and eight female) consumed breakfast study foods containing 25 g available carbohydrate on seven occasions over a 3- to 9-week period: food 1: D-glucose (25 g) served as the control and was consumed on three separate occasions; food 2: GMY (617·28 g); food 3: Corinthian raisins (37·76 g); food 4: Sultana raisins (37·48 g) and food 5: GMY & C (308·64 g GMY and 18·88 g C). Postprandial glucose was measured over a 2 h period for the determination of GI and glycaemic load (GL). Subjective appetite ratings (hunger, fullness and desire to eat) were assessed by visual analogue scales (100 mm) at 0–120 min. Blood pressure (systolic and diastolic; BP) was measured at baseline and 120 min. GMY provided low GI (26), C and S provided high GI/low GL (75/10 and 70/9, respectively) and GMYC provided low GI (47) values on glucose scale compared with D-glucose. Peak blood glucose rise was significantly lower only for GMY and GMYC compared with reference food (D-Glucose), as well as C and S ( < 0·05). No differences were observed between test foods for fasting glucose, BP and subjective appetite. In conclusion, GMY and GMYC attenuated postprandial glycaemic responses, which may offer advantages to glycaemic control.
Topics: Male; Female; Animals; Appetite; Vitis; Milk; Blood Pressure; Yogurt; Blood Glucose; Glucose; Glycemic Index; Peptides; Angiotensins; Goats; Postprandial Period; Cross-Over Studies; Insulin
PubMed: 35920045
DOI: 10.1017/S0007114522002537 -
Diabetes, Obesity & Metabolism Dec 2023To provide a preliminary evaluation of the accuracy and safety of Gluclas decision support system suggestions in a hypoglycaemic clamp study.
AIM
To provide a preliminary evaluation of the accuracy and safety of Gluclas decision support system suggestions in a hypoglycaemic clamp study.
METHODS
This analysis was performed using data from 32 participants (four groups with different glucose-insulin regulation: post Roux-en-Y gastric bypass with and without postprandial hypoglycaemia syndrome, postsleeve gastrectomy and non-operated controls) undergoing Gluclas-assisted hypoglycaemic clamps (target: 2.5 mmol/L for 20 minutes at 150 minutes after oral glucose ingestion). Gluclas provided glucose infusion rate suggestions upon manual entry of blood glucose values (every 5 minutes), which were either followed or overruled by investigators after critical review. Accuracy and safety were evaluated by mean absolute error (MAE), mean absolute percentage error (MAPE), average glucose level, coefficient of variation (CV) and minimal glucose level during the 20-minute hypoglycaemic period.
RESULTS
Investigators accepted 84% of suggestions, with a mean deviation of 30.33 mg/min. During the hypoglycaemic period, the MAE was 0.16 (0.12-0.24) (median [interquartile range]) mmol/L and the MAPE was 6.12% (4.80%-9.29%). CV was 4.90% (3.58%-7.27%), with 5% considered the threshold for sufficient quality. The minimal glucose level was 2.40 (2.30-2.50) mmol/L.
CONCLUSIONS
Gluclas achieved sufficiently high accuracy with minimal safety risks in a population with differences in glucose-insulin dynamics, underscoring its applicability to various patient groups.
Topics: Humans; Blood Glucose; Glucose; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulins
PubMed: 37681278
DOI: 10.1111/dom.15265 -
Drug Design, Development and Therapy 2024This study compared the pharmacokinetics, safety and bioequivalence (BE) of generic and original apremilast tablets in healthy Chinese subjects under fasting and... (Randomized Controlled Trial)
Randomized Controlled Trial Clinical Trial
OBJECTIVE
This study compared the pharmacokinetics, safety and bioequivalence (BE) of generic and original apremilast tablets in healthy Chinese subjects under fasting and postprandial conditions, providing sufficient evidence for abbreviated new drug application.
METHODS
A randomized, open-label, two-formulation, single-dose, two-period crossover pharmacokinetic study was performed. Thirty-two eligible healthy Chinese subjects were enrolled in fasting and postprandial studies, respectively. In each trial, subjects received a single 30-mg dose of the test or reference apremilast tablet, followed by a 7-day washout interval between periods. Serial blood samples were obtained for up to 48 h post-intake in each period, and the plasma concentrations of apremilast were determined by a validated method. The primary pharmacokinetic (PK) parameters, including the maximum plasma concentration (C), the areas under the plasma concentration-time curve (AUC, AUC), were calculated using the non-compartmental method. The geometric mean ratios of the two formulations and the corresponding 90% confidence intervals (CIs) were acquired for bioequivalence analysis. The safety of both formulations was also evaluated.
RESULTS
Under fasting and postprandial states, the PK parameters of the test drug were similar to those of the reference drug. The 90% CIs of the geometric mean ratios of the test to reference formulations were 94.09-103.44% for C, 94.05-103.51% for AUC, and 94.56-103.86% for AUC under fasting conditions, and 99.18-112.48% for C, 98.79-106.02% for AUC, and 98.95-105.89% for AUC under postprandial conditions, all of which were within the bioequivalence range of 80.00-125.00%. Both formulations were well tolerated, and no serious adverse events occurred during the study.
CONCLUSION
The trial confirmed that the PK parameters of the generic and original apremilast tablets were bioequivalent in healthy Chinese subjects under fasting and postprandial states, which met the predetermined regulatory standards. Both formulations were safe and well tolerated.
CLINICAL TRIAL REGISTRATION
chinaDrugtrials.org.cn, identifier CTR20191056 (July 30, 2019); chictr.org.cn, identifier ChiCTR2300076806 (October 19, 2023).
Topics: Humans; Therapeutic Equivalency; Thalidomide; Fasting; Postprandial Period; Adult; Male; Cross-Over Studies; Healthy Volunteers; Tablets; Young Adult; Female; Anti-Inflammatory Agents, Non-Steroidal; Asian People; Area Under Curve; Administration, Oral
PubMed: 38895175
DOI: 10.2147/DDDT.S461771