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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02445508 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effect of Bile Acid Secretion and Sequestration on GLP-1 Secretion

Start date: May 2015
Phase: N/A
Study type: Interventional

Accumulating evidence suggests that bile acids in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile acids can lead to changes in gut hormone secretion and consequently affect glucose homeostasis. The current study is a human interventional randomized controlled cross-over study including four study days for each participant. As a tool to sequester bile acids we will use sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with chronic kidney disease. Surprisingly, sevelamer has been shown to improve glycaemic control in patients with chronic kidney disease and type 2 diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The aim is to examine how (and if) bile acid sequestration can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2 diabetes. The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in gut hormone secretion. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion and glucose metabolism.

NCT ID: NCT02445079 Completed - Hypertension Clinical Trials

Ugandan Non-Communicable Diseases and Aging Cohort

UGANDAC
Start date: December 2013
Phase:
Study type: Observational

Longitudinal cohort study of older-aged people living with HIV infection in southwestern Uganda and age and gender-matched HIV uninfected controls with the primary aim of measuring the epidemiology of cardiovascular and pulmonary disease in this study setting, and particularly the contribution of HIV infection to it.

NCT ID: NCT02444910 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects of KDT501 on Metabolic Features in Insulin Resistant Subjects

Start date: April 2015
Phase: Phase 2
Study type: Interventional

KDT501 is an orally administered product designed to help control impaired glucose and insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein receptors. Nonclinical studies have also documented the ability of KDT501 to improve insulin sensitivity and glucose regulation as well as reduce proinflammatory signals. These properties combined with antihyperglycemic activity and modest, partial agonist effect of KDT501 at the peroxisome proliferator-activated receptor-gamma (PPARγ) receptor suggests an atypical and pleiotropic mechanism of action for KDT501. Following providing informed consent, potential subjects will undergo screening procedures to ensure that they meet all inclusion and exclusion criteria. Following registration on study, subjects will undergo baseline pretreatment studies, including two abdominal fat biopsies, one taken after cold challenge, as well as determination of resting metabolic rate, a 4 hour lipid tolerance test, and a 2 hour euglycemic clamp study. All pretreatment studies in registered subjects will be performed within 7 days prior to initiating therapy. On the first day of treatment (Day 0), subjects will take the first 600 mg dose of KDT501 in the clinic, followed by serum pharmacokinetic (PK) samples being obtained every hour for 6 hours after dosing. Subjects will then continue dosing as an outpatient, 600 mg po twice daily. All doses will be taken with meals (breakfast and dinner). On Day 7, subjects will return to the clinic to undergo safety and laboratory assessments, including PK. On Days 14 and 21, subjects will again return to the clinic to undergo safety and laboratory assessments. On Day 17 subjects will return to the clinic for PK studies, as noted below. Treatment in all subjects will end on Day 28. Rapid PK assessment of drug exposure, defined as AUC0-12h, will be performed following PK samples drawn at Time 0, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, and 12h on both Days 7 and 17. On Days 11 and 21 (±1day), based on the KDT501 drug exposure level, the subject will be provided instructions on dose adjustments of KDT501. The maximum allowed KDT501 exposure ceiling for all subjects enrolled is AUC0-12h = 22,500ng-hr/mL.

NCT ID: NCT02444156 Completed - Clinical trials for Diabetes Mellitus, Type 2

Rowing Away From Diabetes

Start date: June 2015
Phase: N/A
Study type: Interventional

Primary research question: What is the effect of indoor rowing, under the ideal circumstances of a laboratory setting, on glucose control in adults with impaired glucose control? Secondary research question: Is it possible to develop a full-scale study of the benefits of indoor rowing under the usual circumstances of a community setting? Why? It is good practice to conduct a small pilot study before embarking on an expensive full-scale study. What? Around 150 minutes of aerobic exercise and around 150 minutes of resistance exercise per week are necessary to meet prevailing recommendations for adults with impaired glucose control. Around 120 minutes of indoor rowing per week might be a less time-consuming alternative to prevailing recommendations because indoor rowing involves a combination of aerobic and resistance exercise. Who? Twenty men and postmenopausal women aged 45-65 years with impaired glucose regulation, such as those with type 2 diabetes. Eligible volunteers will not have smoked in the last year, will not have exercised regularly in the last six months, and will not be taking any form of diabetes medication other than metformin. Eligible volunteers will have stable weight and a body mass index of 25-40. Where and how? Before and after the exercise intervention, glucose control (postprandial blood glucose concentrations) will be assessed at Leicester Diabetes Centre and cardiac function (MRI) will be assessed at Glenfield Hospital. During the exercise intervention, participants will use an indoor rower three times per week for 12 weeks at Leicester Diabetes Centre. Participants will be taught how to row correctly and the duration and intensity will gradually increase. In order to inform the design of a full-scale trial, recruitment rate will be assessed, adherence will be monitored, and a third party will interview participants to find out if the intervention and assessments are feasible and acceptable.

NCT ID: NCT02443155 Completed - Diabetes Clinical Trials

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Start date: November 10, 2015
Phase: Phase 2
Study type: Interventional

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

NCT ID: NCT02441504 Completed - Clinical trials for Diabetes Mellitus, Type 1

Effects of Low Intensity Aerobic Exercise on the Microvascular Endothelial Function of Patients With Type 1 Diabetes

Start date: January 2014
Phase: N/A
Study type: Interventional

Background: The aim of the present study was to evaluate the changes in the microvascular density and reactivity in patients with type 1 diabetes (T1D) resulting from low intensity chronic exercise training. Methods: This study included 22 (34 ± 7 years) consecutive outpatients with T1D and disease duration > six years. We used intravital video-microscopy to measure the basal skin capillary density as well as capillary recruitment using post-occlusive reactive hyperemia (PORH) in the dorsum of the fingers. Endothelium-dependent and -independent vasodilation of the skin microcirculation was evaluated in the forearm with a laser Doppler perfusion monitoring (LDPM) system in combination with acetylcholine and sodium nitroprusside iontophoresis, PORH and local thermal hyperemia.

NCT ID: NCT02439684 Completed - Diabetes Mellitus Clinical Trials

Can HbA1c Replace OGTT for the Diagnosis of Diabetes Mellitus Among Chinese Patients With IFG?

Start date: May 2013
Phase: N/A
Study type: Observational

This is a cross-sectional study that aims to assess the sensitivity and specificity of using HbA1c as a diagnostic test for detecting the presence of diabetes mellitus (DM) when compared to the use of oral glucose tolerance test (OGTT) among Hong Kong Chinese adult who have impaired fasting glucose (IFG). The investigators will recruit around 1000 non-diabetic adult participants who have impaired fasting glucose (i.e. fasting glucose level between 5.6 to 6.9mmol/L) AND without symptoms of hyperglycaemia to undergo both HbA1c test and oral glucose tolerance test after obtaining their informed consent. A diagnosis of DM is confirmed when both the fasting glucose level and 2-hour-post challenge plasma glucose level fall into diabetic range (i.e. fasting glucose level ≥7.0mmol/L and 2-hour-post challenge plasma glucose level ≥11.1mmol/L) after a standard 75g OGTT. Participants with only 1 plasma glucose value within the diabetic range will be invited to repeat an oral glucose tolerance test for confirmation of their diagnosis as recommended by American Diabetes Association and World Health Organization. Demographic data of the participants including age, gender, smoking status, medical history, diet and activity level will be collected. Lipid profile, blood pressure, waist circumference and body mass index will be checked and the total cardiovascular risk in 10 years will be calculated for each participant using the Joint British Societies 2005 and Framingham 2008 equations to evaluate the baseline cardiovascular risk of the participants. These data will be analyzed using SPSS. The primary outcomes are the sensitivity and specificity of HbA1c in detecting diabetes mellitus diagnosed by oral glucose tolerance test (the gold standard). A receiver operating characteristic (ROC) curve will be obtained by plotting sensitivity against (1-specificity) for each cutoff value for identification of an optimal cutoff point. Diagnostic accuracy will be assessed by the area under the curve (AUC). The differences in characteristics among participants diagnosed to have diabetes mellitus by oral glucose tolerance test or HbA1c will be compared using independent t-test or χ2 test for comparison between the 2 groups.

NCT ID: NCT02437747 Completed - Diabetes Mellitus Clinical Trials

Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus

Start date: June 2014
Phase: Phase 4
Study type: Interventional

A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.

NCT ID: NCT02436369 Completed - Diabetes Mellitus Clinical Trials

The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients

Start date: September 2014
Phase: N/A
Study type: Interventional

The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.

NCT ID: NCT02435693 Completed - Clinical trials for DIABETES MELLITUS, TYPE 2

Pharmaceutical Care Program for Type 2 Diabetes Mellitus

pcp
Start date: July 2012
Phase: N/A
Study type: Interventional

Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule Objectives:- 1. To evaluate Pharmaceutical care program in Type2 diabetics. 2. To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus. 3. To study the prevalence of Type2 diabetics cases in Dhule. 4. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics. 5. To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus. 6. To study the impacts of Pharmaceutical care program on glycemic control in patients with Type-2 Diabetes Mellitus. 7. To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital Dhule. 8. To compare the efficiency of Pharmaceutical care program and drug in patients with Type-2 Diabetes Mellitus. 9. To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's. 10. To increase the patient compliance and positive attitude of patients towards the diabetes disease by counseling.