Active clinical trials for "Diabetes Mellitus, Type 2"

This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM).

The purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (PF-07081532). People with certain level of kidney functional impairment may process PF-07081532 differently from healthy people. PF-07081532 is developed as a potential treatment for type II diabetes. Participants will take the study medicine as a tablet by mouth once at the study clinic and then will stay at the study clinic for about 7 days. During that time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain degree of kidney functional impairment will have an effect on the study medicine PF-07081532.

This study will investigate the potential benefit of scheduled natural daylight exposure to improve glucose control in type 2 diabetes (T2D) patients and to unravel molecular mechanisms underlying the effects of natural daylight on circadian clocks and (glucose) metabolism in human skeletal muscle from T2D patients. Participants will stay at our research facilities and will be exposed to natural daylight or artificial light during the daytime over 4.5 days in a randomized cross-over design. For both conditions, the evening and night will be spent under standardized dim and dark conditions.

Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates. One important aspect of the high-quality carbohydrate characteristics is a slow and sustained digestion and glucose release to the blood. In the proposed study, the investigators will evaluate the consumption of different types of slowly digestible carbohydrates (SDCs) and their beneficial effects including moderation of the glycemic response profile (postprandial glycemic response, PPGR) and stimulation of the gut-brain axis, which controls appetite and food intake. This stimulation will be evaluated in terms of second-meal food intake and the circulatory level of appetite-suppressing gut hormones (such as glucagon-like peptide-1).

Aim: To evaluate the effect of nutrition education intervention (NEI) on glycemic control and other diabetes-related outcomes of patients with type 2 diabetes mellitus (T2DM), at a tertiary health Center, in Basrah, Iraq. Participants and setting: The study was involved 208 participants (20-64 years) diagnosed with T2DM at least 6 months before the study and had poorly controlled diabetes (HbA1c ≥ 7%). The study setting is the outpatient clinics at a tertiary health Center in Basrah, Iraq. Intervention: This randomized controlled trial design. The participants were allocated to either intervention group (IG), or control group (CG). A total sample size was 208 participants with T2DM (104 per group) to detect a 5% reduction in glycemic control (HbA1c), at visit time 1 (3 months after intervention) and visit time 2 (3 months after following up) and allowing 30% drop out rate. The intervention period is 22 weeks long with the following mechanisms: the curriculum (twelve weekly classes, 1 to 1.5 hrs. each); follow-up classes (one monthly each lasting 1 to 1.5 hrs.); nutrition education materials (pamphlets) and reminder calling before each session for IG. The participants in the CG received classes about diabetes and its complications with some advice related to physical activity on different days on IG. Besides, they received the same pamphlets at the end of the study. Both groups continued with the usual medical care at respective Center. The participants in the IG group received nutrition education classes. The classes are offered in the meeting hall in the center by face- to- face using the simple Arabic language, which utilized lecture method using PowerPoint presentations and whiteboard, lecture-discussion groups, and related videos. The nutrition education classes were administered by a nutritionist and a team of endocrinologists, and diabetes experts. The content and strategies utilized in the classes were based on Health Belief Model theory (HBM). Outcomes: the outcomes were evaluated at visit time 1 (at 12 weeks of intervention) and at visit time 2 (at 22 weeks of the follow-up period) for both groups. The outcomes were included HbA1c, metabolic parameters, nutritional status, HBM constructs, diabetes knowledge (DK), and health literacy (HL). It is assumed that the NEI will reduce the HbA1c levels by at least 0.5% at three months and the levels will be lower in IG compared with CG, and the lower levels will be continued at 22 weeks in IG.

The highly promising and innovative tracer on 111In-DTPA-AHX-Lys40-Exendin 4 has been applied to determine beta cell mass in healthy volunteers and patients with type 1 diabetes. However, the high retention of the tracer in the kidneys was leading to a kidney/pancreas uptake ratio of 41±23. This high renal uptake is complicating absolute BCM quantification by SPECT imaging. In order to reduce the kidney/pancreas uptake ratio, investigators propose a co-infusion with the plasma expander Gelofusine since it has been shown in several pre-clinical and clinical studies that Gelofusine can reduce the renal retention of several other, closely related tracers. When investigators are able to reduce the kidney/pancreas uptake ratio, these findings will improve the interpretation of clinical quantitative SPECT, having important implications for therapeutic decision making for patients with diabetes, insulinomas or congenital hyperinsulinism, and may also have a major impact on our understanding of the pathophysiology of these diseases.

Our recent data in mice have demonstrated a key role of xanthine oxidase in hyperglycemia-induced by Reactive oxygen species production, and a preventive role of allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2 diabetic patients.

The aim is to continue our program on PDE5 inhibition by evaluating effects on insulin resistance, including glucose metabolism and subclinical inflammation, after a 6-week administration of tadalafil in T2D patients. The primary objective is to study the effect of tadalafil compared with placebo on insulin sensitivity during a euglycemic hyperinsulinemic clamp. This is a double-blind, placebo-controlled crossover study with one study site. Twenty-five T2D patients will be recruited and randomized to per oral intake of tadalafil 20 mg o.d. for six weeks and after a wash-out period of eight weeks intake of placebo for another six weeks, or vice versa. At the end of each 6 week treatment period a glucose clamp, subcutaneous needle biopsies as well as muscle and subcutaneous microdialysis will be performed. Endothelial function tests and arginin stimulation of insulin secretion tests will be performed after 3 weeks in each treatment arm.

The purpose of this trial is to explore the impact of the Gather Health diabetes management platform diabetics' health behaviors and health outcomes and how providers and diabetics interact with the Gather Health platform.

The aim of the study is to test the effect of a new shared care model for type 2 diabetes care and compare it with a standardized care management program in a specialized hospital-based out-patient clinic. The hypothesis is that participants with type 2 diabetes followed in a shared care program will have a comparable outcome in HbA1c to participants receiving standard care.