scholarly journals Response to Twin Enabled Precision Treatment for Reversing Diabetes: An Initial Analysis at 4 Weeks of the Ongoing Randomised Controlled Trial

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A474-A475
Author(s):  
Paramesh Shamanna ◽  
Mala Dharmalingam ◽  
Arun Vadavi ◽  
Jahangir Mohammed ◽  
Terrence Poon ◽  
...  

Abstract Introduction: Technology enabled precision nutrition, a combination of macro, micro and biota nutrients, along with Continuous Glucose Monitoring (CGM) have been demonstrated to be a key for reversal of diabetes. Methods: We conducted an initial analysis (n=23) of the ongoing randomized controlled trial of Twin Precision Treatment (TPT): a novel whole-body digital twin enabled precision treatment for reversing diabetes. The clinical and the biochemical parameters were evaluated as the longitudinal follow up at the first follow up visit at 4 weeks. The target sample size is 300 with an estimated duration of 5 years. Descriptive statistics were used Results: 8/23 (35%) patients achieved the intended outcome of reversal of HbA1c and off any anti-diabetic medications. There was a statistically significant improvement in HbA1c % (8.5 ± 1.6 to 6.8 ± 0.66; p<0.0001), Fasting Blood Glucose mg/dL (FBS) (151 ± 44 to 98 ± 18; p<0.0001), HOMA2-IR (1.7 ± 0.64 to 1 ± 0.45; p=0.0001), HOMA2-Beta (53 ± 28 to 86 ± 38; p=0.0013), Systolic BP (129 ± 11 to 120 ± 11; p=0.008) and serum albumin g/dL (4.5 ± 0.21 to 4.2 ± 0.31; p=0.0042). The baseline values for the other parameters including body weight, waist circumference, Diastolic BP, Alanine transaminase (ALT), Gamma-glutamyl transferase (GGT), eGFR, WBC, Platelet, Globulin, ESR, demonstrated a clinically relevant, superior change Discussion: The initial analysis for the prospectively designed trial reveals a remarkable improvement in the clinical and the biochemical parameters that would determine the complete and the prolonged remission of diabetes. The initial results are an early indicator for the translation of the scientific rationale for the technological intervention, through digital twin technology, powered by Internet of Things (IoT) and Artificial Intelligence (AI), as a modality to enable reversal of diabetes into an achievable outcome that would be durable. The impactful glycemic control appears to have positive meaningful metabolic health consequences Trial Registration: The trial has been prospectively registered in Clinical Trial Registry – India: Reference no. CTRI/2020/08/027072 on August 10, 2020

2021 ◽  
Author(s):  
Fei Teng ◽  
Peng Lai ◽  
Liying Wang ◽  
Xuekui Liu ◽  
Houfa Geng ◽  
...  

Abstract Objective The aim of this study was to identify the relationships between gamma−glutamyltransferase (GGT) and fasting blood glucose (FBG) during a 6-year follow-up of subjects, and to evaluate if GGT is an independent factor affecting FBG. Methods Total of 1369 individuals from health examination survey at the urban area of Xuzhou, central China, were followed up for 6 years. The patients were divided into four groups according to their baseline GGT levels (in quartiles). The one-way ANOVA method was used to compare the differences of variables with basic line. The relationship between GGT and FBG levels was examined using repeated measurements ANOVA. Results The grouping of baseline GGT levels influenced changes in blood glucose during 6-year follow-up. In GGT quartile subgroups, the annual mean increase of FBG level shows a positive relationship with baseline GGT level. And this trend was even more pronounced in the highest baseline GGT group. Time course, baseline FBG and GGT groups at different individuals, which together affected the change of FBG level during the follow-up. Considering that baseline FBG may affect subsequent FBG levels, repeated measures ANOVA was used to exclude the effect of this factor. Results showed that different baseline GGT groups were still significantly associated with increased FBG levels during follow-up. GGT is an independent factor affecting FBG level(p<0.001). Conclusions The annual mean increase of FBG level shows a positive relationship with baseline GGT level. Higher baseline GGT levels resulted in a faster annual mean increase in FBG. GGT could be used for early detection of impaired fasting glucose regulation (IFG) patients in clinical field.


2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Rebecca Paprott ◽  
Christa Scheidt-Nave ◽  
Christin Heidemann

Previous studies investigating determinants of changes in glycemic status among individuals with prediabetes mainly focused on glucose-defined prediabetes. In this study, we examined determinants of a regression to normoglycemia or a progression to diabetes among individuals with HbA1c-defined prediabetes. The study included 817 participants (18–79 years) with prediabetes (HbA1c 5.7–6.4% (39–47 mmol/mol)) at baseline. Glycemic status at follow-up was categorized as diagnosed diabetes (self-reported physician diagnosis or antidiabetic medication), undiagnosed diabetes (HbA1c ≥ 6.5% (≥48 mmol/mol)), prediabetes (as defined at baseline), and normoglycemia (HbA1c < 5.7% (<39 mmol/mol)). Determinants of glycemic changes were identified by multinomial logistic regression (OR (95% CI)), with those remaining in the prediabetic state as reference. During a mean follow-up time of 12.0 years, 33.8% of the participants reverted to normoglycemia, 7.2% progressed to undiagnosed diabetes, 12.8% progressed to diagnosed diabetes, and 46.2% remained prediabetic. Determinants of a regression to normoglycemia were female sex (male vs. female: 0.67 (0.46; 0.98)) and higher HDL cholesterol levels (1.17 (1.02; 1.35) per 10 mg/dl). Determinants of a progression to undiagnosed or diagnosed diabetes were higher values of BMI (1.10 (1.02; 1.18); 1.13 (1.06; 1.21) per kg/m2), waist circumference (1.04 (1.01; 1.07); 1.06 (1.03; 1.09) per cm), alanine aminotransferase (1.06 (1.03; 1.09); 1.07 (1.03; 1.10) per U/l), and gamma-glutamyl transferase (1.02 (1.00; 1.03); 1.03 (1.01; 1.04) per U/l). Higher age (1.04 (1.02; 1.06) per year), female sex (male vs. female: 0.56 (0.33; 0.97)), and parental history of diabetes (yes vs. no: 1.82 (1.05; 3.15)) were further associated with a progression to diagnosed diabetes, whereas higher triglyceride levels (1.03 (1.01; 1.06) per 10 mg/dl) were associated with a progression to undiagnosed diabetes. In conclusion, among the investigated determinants, potentially modifiable anthropometric and metabolic markers were associated with glycemic changes in individuals with HbA1c-defined prediabetes. The findings of this study demonstrate the need for more refined case finding strategies for diabetes prevention.


2016 ◽  
Vol 42 (02) ◽  
pp. 53-67
Author(s):  
Shang-Hsiu Chung ◽  
Li-Wen Chang ◽  
Tsun-Li Cheng ◽  
Chen-Jou Lin ◽  
Wen-Ying Chen ◽  
...  

Reference interval (RIs) were critical to the identification of illness. However, RIs set in one laboratory may not be appropriate for another because of biological, geographical and instrumental factors. Interpretation of clinical data using inappropriate RIs may cause misclassification of results and misdiagnosis that lead to improper treatment. RIs in Taiwan have been mostly referencing from foreign resources, it is desirable to establish one that is closer to the overall conditions in Taiwan (such as breed, climate, diseases, etc.) and to investigate its differences to foreign RIs. The present study used the American Society for Veterinary Clinical Pathology (ASVCP) guidelines to establish in-house RIs for hematological, biochemical and coagulation parameters using dogs in middle Taiwan. The results were also compared to two foreign and one local RIs. The results suggested that the hematological RIs are more comparable to foreign RIs than the biochemical and hemostatic parameters. Differences were found for biochemical parameters including gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), lipase, uric acid, bile acid, bilirubin and magnesium; and coagulation parameters including prothrombin time (PT) and activated partial thromboplastin. In all, 18% (7/40) of the all tested parameters were different from the local RI while 38% (18/48) and 41% (19/46) of the parameters were different from the two foreign RIs. The differences in more than 30% RIs and better similarities to local RIs underscore the importance of having own RIs if possible.


2020 ◽  
Author(s):  
Jianfu Zhou ◽  
Rongwu Lin ◽  
Xuehua Liu ◽  
Liguo Lv ◽  
Shusheng Wang ◽  
...  

Abstract BackgroundHot flashes, characterized by intense heat sensation and diaphoresis, are common side effects resulted from hormonotherapy in patients with prostate cancer. Cumulated studies have revealed beneficial role of acupuncture as complementary and alternative recipe for the management of hot flashes. However, little is known about the auricular acupressure (AA), a micro-acupuncture technique whose therapeutic purpose is similar with conventional acupuncture. Therefore, this current study aims to explore the effects and determine the feasibility of AA for hot flashes in patients with prostate cancer.Methods/DesignThis proposed pilot study is a two-arm parallel, single-blinded, randomized sham-controlled trial. A total of 72 participants of prostate cancer suffered with hot flashes will be recruited and randomly allocated into two groups in a 1:1 ratio. Equal randomization is conducted using a computer-generated random allocation sequence. Sheng Zhi Qi (TF2), Nei Fen Mi (CO18), Shen Men (TF4), Shen (CO10) and Pi Zhi Xia (AT4) are selected as experimental acupressure points, and five helix points (HX 8-12) are used as sham control acupressure points. Participants in the experimental group and control group will receive AA and sham-AA treatment, respectively. The duration of the treatment is 6 weeks with two sessions per week, and the follow-up period is 12 weeks. The primary outcome is Hot Flash Score (HFS). The secondary outcomes include Quality of Life (QoL), Pittsburgh Sleep Quality Index (PSQI) and Hamilton Anxiety Scale (HAS). All outcomes measurement will be conducted before and through treatment period as well as follow-up period. Safety assessment will be carried out through treatment and follow-up period.DiscussionThis pilot study will for the first time advance our knowledge on feasibility of AA in alleviating hot flashes in patients of prostate cancer and provide preliminary evidence for a further full-scale trial.Trial registrationChinese Clinical Trial Registry, ChiCTR1900026694. Registered on 19 October 2019.


2020 ◽  
Vol 8 (2) ◽  
pp. e001229
Author(s):  
Sylvia H Ley ◽  
Jorge E Chavarro ◽  
Stefanie N Hinkle ◽  
Mengying Li ◽  
Michael Y Tsai ◽  
...  

IntroductionLonger duration of lactation is associated with lower cardiometabolic disease risk, but pathogenic pathways involved in the disease progression are unclear, especially among high-risk women. We aimed to examine the associations of lifetime lactation duration with cardiometabolic biomarkers among middle-aged women with a history of gestational diabetes (GDM).Research design and methodsWomen with a history of GDM participating in the Nurses’ Health Study II, a prospective cohort study, were identified and followed through biennial questionnaires beginning in 1991. Lactation history was asked in three follow-up questionnaires to calculate lifetime duration. In 2012–2014, fasting blood samples were collected through the Diabetes & Women’s Health Study to measure inflammatory (C-reactive protein (CRP), interleukin (IL) 6), liver enzyme (alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase), and lipid biomarkers (total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol).ResultsAt follow-up blood collection, women were at median age 58.2 (95% CI 51 to 65) years and 26.3 (95% CI 15.7 to 34.1) years since GDM index pregnancy. After multiple adjustment including prepregnancy body mass index (BMI), longer duration of lactation was significantly associated with lower CRP (least squares (LS) mean 1.90 mg/L (95% CI 1.47 to 2.45) for 0-month lactation, 1.98 mg/L (95% CI 1.68 to 2.32) for up to 12-month lactation, 1.67 mg/L (95% CI 1.42 to 1.97) for 12–24 month lactation, and 1.39 mg/L (95% CI 1.19 to 1.62) for >24-month lactation; p trend=0.003) and IL-6 (1.25 pg/L (95% CI 0.94 to 1.68), 1.19 pg/L (95% CI 0.99 to 1.42), 1.04 pg/L (95% CI 0.87 to 1.25), and 0.93 pg/L (95% CI 0.78 to 1.11); p trend=0.04). Longer duration of lactation was associated with lower risk for chronic inflammation using CRP 3 mg/L cut-off in middle-aged women (OR 0.81 (95% CI 0.69 to 0.940 per 1-year increase) with multiple adjustment.ConclusionsLonger lifetime duration of lactation was associated with favorable inflammatory biomarker concentrations in middle-aged women with a history of GDM. Chronic inflammatory pathways may be responsible for previously reported associations between lactation and long-term risk for cardiometabolic diseases.


2019 ◽  
Vol 10 (1) ◽  
Author(s):  
Danielle Cristiane Baldo ◽  
Alessandra Dellavance ◽  
Maria Lucia Gomes Ferraz ◽  
Luis Eduardo C. Andrade

Abstract Background Anti-mitochondria autoantibodies (AMA) occur in > 95% primary biliary cholangitis (PBC) patients. Biochemically normal AMA-positive (BN/AMA+) individuals, occasionally noticed by indirect immunofluorescence (IIF) on HEp-2 cells and confirmed in AMA-specific assays, may represent early stages of PBC. The Enhanced Liver Fibrosis (ELF) score is a surrogate marker for liver fibrosis. This prospective study investigated the ELF score in BN/AMA+ individuals and PBC patients, considering autoantibody avidity and serum levels along the years. Methods 327 samples from 35 PBC and 59 BN/AMA+ were prospectively obtained in average 3.83 (range 0.50–7.40) years apart. Samples were tested by IIF on rat-kidney (IIF-AMA), western-blot for AMA (WB-AMA), and ELISA for antibodies against pyruvate-dehydrogenase (PDC-E2), gp210, sp100 and CENP-A/B. Anti-PDC-E2 avidity was determined by 6 M urea-elution ELISA. Alkaline phosphatase (ALP), gamma glutamyl transferase (ɣGT) and ELF score were measured by automated methods. Results Along the follow-up period BN/AMA+ subjects and PBC patients presented significant increase in serum anti-PDC-E2 (mean 10.45% and 8.86% per year; respectively), anti-PDC-E2 avidity (3.02% and 4.94%/year) and ELF score (3.24% and 2.71%/year). IIF-AMA and ɣGT increased in BN/AMA+ (6.59% and 2.36%) and decreased in PBC (− 4.89%/year and − 3.88%/year). In BN/AMA+ individuals there was positive correlation of ELF with IIF-AMA titer (r = 0.465; p < 0.001) and with anti-PDC-E2 levels (r = 0.239; p < 0.001). Expansion of autoantibody targets along time occurred in 39% BN/AMA+ and 49% PBC patients. The frequency of BN/AMA+ with high probability of having established PBC increased from 7 to 14%. Conclusions BN/AMA+ individuals present an orchestrated increase in ELF score and humoral autoimmune response over time, indicating an opportunity for early therapeutic intervention and prevention in autoimmunity.


2011 ◽  
Vol 26 (S1) ◽  
pp. s156-s156
Author(s):  
M. Ortatatli ◽  
R. Gumral ◽  
H. Uckardes ◽  
M. Eroglu ◽  
L. Kenar ◽  
...  

Crimean-Congo Hemorrhagic Fever (CCHF) is a fatal zoonotic viral infection. The agent belongs to the Nairovirus of the Bunyaviridae species. The virus naturally recycles in vector-vertebrate-vector. This study aimed to evaluate cases of tick bites admitted to Infectious Diseases and Emergency Departments in 2008, and to develop management recommendations of such cases. Fifty-seven patients who admitted to a hospital due to tick bites in 2008 were included in the study. A 10-day clinical follow-up was performed to assess for symptoms including fever, fatigue, abdominal pain, headache, nausea/vomiting, diarrhea, disseminated somatic pain, and other hemorrhagic signs. During this period, laboratory analyzes, including white blood cells, thrombocytes, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, lactate dehydrogenase, creatinine phosphokinase (CK), and pentylenetetrazol were performed. Personal data of the patients, location of the bite, and the removal of the tick were recorded.ResultsOf the 57 patients, 37% were from the city, and 63% were from rural areas. The tick was removed by health staff in 25 (44%) of the cases. The bites occurred on body areas including the head/neck, trunk, upper extremities, and lower extremities in 14%, 24%, 27%, and 13% of the cases, respectively. During the follow-up period, none of the patients exhibited any of the signs or symptoms listed above. Laboratory tests did not reveal any abnormalities, except for high levels of CK in 15 patients. Thus, 57 cases did not develop CCHF.Discussion and ConclusionSince 2002, CCHF has caused an increased mortality in Turkey, and has resulted in high anxiety and concern among the Turkish public regarding tick bites. This has resulted in a rise in the number of patients admitting to emergency departments with tick bites. Due to CCHF's incubation period, patients with tick bites should be evaluated for 10 days using a multidisciplinary approach involving both clinical and laboratory evaluations in order to prevent the unnecessary administration of ribavirine.


2021 ◽  
Author(s):  
Lotfi S. Bin Dahman ◽  
Mariam A. Humam ◽  
Nabil S. Musiaan ◽  
Ahmed M. Daakik ◽  
Mohammed A. Balfas

Abstract This case-control study was aimed to assess the association between liver enzymes and incident T2D in Yemeni patients. The present study comprising 142 T2D patients and 142 healthy control subjects were recruited from the diabetic outpatient clinic of Ibn-Sina Hospital in Mukalla during the period from 1st January to 30th May 2020. Serum fasting blood glucose (FBG), total cholesterol, triglyceride, high-density lipoprotein cholesterol (HDL-C), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) were analyzed using the Cobas Integra Plus 400 autoanalyzer. Anthropometric and blood pressure measurements were taken from each participant. T2D patients had significantly higher FBG (P= <0.0001), total cholesterol (P= <0.0001), LDL-C (P= <0.0001), and GGT (P= <0.0001) while, HDL-C was significantly lower in T2D patients (P= 0.021). Serum ALT and GGT levels were significantly associated with increased incident T2D risk (P= 0.006 for ALT and 0.022 for GGT), and the odds ratios at 95% CI comparing the highest versus lower tertiles of ALT and GGT were 2.75(2.01-3.48) and 1.17(1.83-6.42) respectively. In conclusion, higher levels of ALT and GGT are positively associated with increased blood glucose levels and are used as predictive biomarkers for developing a higher risk of diabetes. Thus, routine screening of ALT and GGT in T2D patients is recommended for the early detection of liver disorders.


2018 ◽  
Vol 74 (1) ◽  
pp. 6047-2018 ◽  
Author(s):  
GULSAH AKGUL ◽  
ZAFER MECITOGLU ◽  
DUYGU UDUM KUCUKSEN ◽  
SEZGIN SENTURK

The aim of the presented study was to evaluate the relationship between adiponectin and non-esterified fatty acids (NEFA), β-hydroxybutyric acid (BHBA), glucose, albumin, Gamma-Glutamyl Transferase (GGT), calcium, phosphorus and Blood Urea Nitrogen (BUN) levels in healthy cows and cows suffering clinical or subclinical ketosis in the early postpartum period. A total of 45 Holstein-Fresian dairy cows, consisting of 15 with clinical ketosis, 15 with subclinical ketosis and 15 healthy controls, was used in the study. Selection of animals was based on blood BHBA levels and urine ketone strip results on day 7 after parturition. Blood adiponectin, NEFA, glucose, albumin, GGT, calcium, phosphorus and BUN were also measured on day 7 postpartum. Adiponectin levels were significantly lower in both Clinical Ketosis and Subclinical Ketosis groups compared to the control group. NEFA levels were higher and glucose and calcium levels were lower in both ketosis groups when compared to the control animals. On the other hand, blood albumin, GGT, phosphorus and BUN levels did not differ among study groups. Based on the results of the study, it can be stated that adiponectin may play a role in the pathogenesis of ketosis. This role could be lower milk yield and better energy balance in early postpartum dairy cows with high adiponectin levels due to increased whole body tissue insulin sensitivity..


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