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Autonomic Neuropathy, Diabetic clinical trials

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NCT ID: NCT05642143 Recruiting - Type 2 Diabetes Clinical Trials

Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy

Start date: February 24, 2023
Phase:
Study type: Observational

Objectives: The goal of this cross sectional clinical trial is to examine the phenotype of bone disease in type 2 diabetes.The main aims are to: 1. Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures. 2. Examine how autonomic and peripheral neuropathy affects bone microarchitecture, bone material strength and bone turnover markers as well as postural control in T2D. Methods: The trial is of cross-sectional design and consists of examinations including - Blood samples to analyze bone markers, glycemic state i.e. - Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure. - Microindentation to evaluate bone material strength - Skin autofluorescence to measure levels of advanced glycation endproducts (AGEs) in the skin - Assesment of nerve function (peripheral and autonomic) - Assesment of postural control, muscle strength and gait Participants: A total of 300 type 2 diabetes patients divided to three groups: - 160 with no history of fractures or diabetic neuropathy - 100 with a history of fracture(s) - 40 with autonomic neuropathy or severe peripheral neuropathy

NCT ID: NCT05389566 Recruiting - Diabetes Clinical Trials

Diabetes, Falls, and Fractures

DIAFALL
Start date: May 6, 2022
Phase:
Study type: Observational

Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements

NCT ID: NCT04193566 Completed - Type 1 Diabetes Clinical Trials

Acute Effects of SGLT2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes

Astronaut
Start date: February 1, 2020
Phase: Phase 4
Study type: Interventional

Background: Inhibiting the sodium-glucose cotransporter-2 (SGLT2) has been observed to reduce risk of cardiovascular events and kidney failure in type 2 diabetes. The exact mechanisms of the beneficial effects of SGLT2 inhibition (SGLT2i) are still unknown. Kidney hypoxia has been demonstrated in diabetic kidney disease and SGLT2i is thought to relieve hypoxia in the kidneys. Mitochondrial dysfunction and autonomic dysfunction might also contribute to kidney hypoxia. Objective: The primary aim of the study is to assess the acute effects of SGLT2 inhibition on parameters reflecting oxygenation and oxygen consumption of the human kidney in persons with type 1 diabetes. Exploratory aims are to investigate acute changes in oxygen availability and oxygen access to the kidneys after SGLT2i. This include measures of peripheral blood oxygenation, mitochondrial function and autonomic function. Methods: Acute intervention study with oral dapagliflozin given in two doses each of 50 mg or matching placebo as intervention. Kidney oxygenation and perfusion parameters will be assessed by blood-oxygen-dependant level magnetic resonance imaging. Mitochondrial function will be assessed by extracellular flux analysis on lymphocytes. Autonomic function will be assessed by measuring baroreflex sensitivity. Design: Randomized, double blinded, placebo-controlled, cross-over intervention study. Study population: Fifteen healthy controls are recruited by advertisement and 15 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen. Endpoints: Primary end-point: Renal cortical and medullary oxygenation (T2*). Exploratory end-points: Renal cortical and medullary perfusion, renal artery flow, renal oxygen consumption, peripheral capillary oxygen saturation (SpO2), arterial oxygen partial pressure (PaO2), arterial oxygen saturation (SaO2), lymphocyte mitochondrial function, baroreflex sensitivity. Timeframe: Inclusion of patients from January 2020. Last patient last visit January 2021. Data analysis completed spring 2021, presentation autumn 2021 and publications Winter 2021.

NCT ID: NCT03930004 Completed - Clinical trials for Diabetes Mellitus, Type 1

Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes

Start date: July 6, 2018
Phase:
Study type: Observational

Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. A possible mechanism for diabetic cardiomyopathy is autonomic dysfunction. This study aims to evaluate cardiac function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.