Type 1 Diabetes Clinical Trial
Official title:
The Influence of Ambient Glycemia on the Effect of Pramlintide on Gastric Emptying in Patients With Type 1 Diabetes and Healthy Subjects
• To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated with subcutaneous (SC) injections of pramlintide.
Status | Completed |
Enrollment | 27 |
Est. completion date | April 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the investigator grants an exception: - Clinical diagnosis of type 1 diabetes (otherwise healthy) with an HbA1 = 9%, and on a stable insulin treatment for at least 3 months (preferably on pump regimen) prior to screening OR is a healthy individual. - 20-40 years of age, inclusive. - Understand and sign an informed consent document, communicate with the investigator, and understand and comply with the requirements of the study. - Euthyroid, including subjects receiving thyroid replacement therapy. If female: - Is surgically sterilized by hysterectomy; OR - Is post-menopausal, as documented by a history of amenorrhea for 6 months and follicle stimulating hormone (FSH) level within the range specified as post-menopausal by the reporting laboratory at screen (post menopausal women on estrogen may enter the study without obtaining an FSH level); OR - If of childbearing potential, meets the following criteria: negative pregnancy test (ß-HCG), regardless of birth control method (including subjects with tubal ligation); - Practicing and willing to continue throughout the study the appropriate contraception (defined as oral, injected, or implanted contraceptives for at least 3 months prior to entry, or barrier contraception). - Agree to take every precaution to ensure that pregnancy will not occur during the study. Exclusion Criteria: - Individuals meeting any of the following criteria are to be excluded from the study unless the investigator grants an exception: - History of severe hypoglycemia. - Body mass index (BMI) = 30 kg/m2. - Autonomic nerve dysfunction: abnormal result in the cardiovascular parasympathetic and/or sympathetic tests (screening visit). Hepatic disease: - Known hepatic disease or transaminases (GOT, GPT) = 2x above normal values. Renal disease: - Known or serum urea, serum creatinine = 1.5x above normal values - Cardiovascular or pulmonary disease: - Arterial hypertension - Blood pressure >150/95 mmHg at screening in a sitting position) - Arterial occlusive disease - Known coronary heart disease - Abnormal ECG at screening visit. - Gastrointestinal disease: - Any known structural gastrointestinal disorder, - Gastrointestinal surgery except for appendectomy, - Symptoms indicating functional or structural upper gastrointestinal disorder (pain, bloating, postprandial fullness, nausea, emesis, - Gastroectomy, gastroparesis, lactose intolerance, and diseases known to alter small bowel absorption; e.g., inflammatory bowel disease. CNS disease: - Epilepsy (including subjects with a past history of convulsions associated with hypoglycaemia), - Psychiatric illness (including history of eating disorder such as bulimia or anorexia). - Autoimmune disease other than thyroid, pernicious anemia, or vitiligo. - Malignant disease requiring chemotherapy, - Any acute febrile illness within 2 weeks of Screening (Visit 1) with a temperature of 100°F, - Currently abusing alcohol or drugs, or have a history of alcohol or drug abuse that in the investigator's opinion could cause the subject to be non-compliant; or have a general history of non-compliance with medications. - Receipt of any investigational drug within 90 days of Screening (Visit 1) (prior treatment with pramlintide is permissible). - Currently treated with medications known to interfere with gastric emptying such as, but not limited to: - Ca2+ channel antagonists, ß-receptor antagonists, prokinetic agents metoclopramide (Reglan®) and cisapride (Propulsid®); and - Chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives. - Currently treated with: - Bile acid sequestering resins cholestyramine (Questran®) and colestipol (Colestid®), - Systemic steroids, - Anti-obesity agents (including orlistat [Xenical®] and sibutramine [Meridia®]), - Alpha-glucosidase inhibitors (acarbose [Precose®] and miglitol [Glyset®]) and meglitinides ([Prandin®] and [Starlix®]). |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich | University of Rochester |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | • To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated with subcutaneous (SC) injections of pramlintide. | 2 years | No | |
Secondary | • Gastric peristalsis derived from high-resolution scintigraphy by means of Fast Fourier Transform (FFT) analysis. • Effects on gastric emptying and on the rate of appearance of ingested glucose appearance, postprandial glucose sequestration, endoge | 2 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|