Clinical trials: Pancreatic Beta Cell Function
Type 1 Diabetes Mellitus
A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes
The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous…
- Trial name
- DIAGNODE-3 (NCT05018585)
- Testing
- Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®, Colecalciferol 2000 IU
- Where
- 60 sites in United States, Czechia and 7 more
- Volunteers
- 321 people
- Sponsor
- Diamyd Medical AB
Type 1 Diabetes
Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
The goal of this clinical study is to evaluate the effect of nutritional intervention program based on dietary products in the clinical treatment of newly diagnosed children with type 1 diabetes.
- Trial name
- TRIM1 (NCT06198725)
- Testing
- Trimtab
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Children's Hospital of Fudan University
Type 1 Diabetes
Verapamil In Preclinical Type 1 Diabetes
Type 1 diabetes (T1D) is preceded by a presymptomatic phase featured by the presence of islet autoantibodies (aAbs) without (Stage 1) or with (Stage 2) dysglycemia.
- Trial name
- VIP-1 (NCT07880769)
- Testing
- Verapamil 120 Mg/24 Hours Oral Capsule, Extended Release, blood sampling, EKG and cardiological evaluation
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Diabetes Mellitus, Type 1, Diabetes Mellitus
Urine Extracellular Vesicles: Non-invasive Biomarkers of Β-cell Function and Novel Therapeutic Agents in Diabetes
Diabetes mellitus is a common chronic disease with a huge socioeconomic burden worldwide. Type 1 Diabetes(T1D) accounts for nearly 95% of diabetes in pediatric age and a lifelong dependence on exogenous insulin.
- Trial name
- EvsBioDiabetes (NCT06832215)
- Testing
- Blood and urine samples collection
- Where
- Portugal
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Unidade Local de Saúde de Coimbra, EPE
Turner Syndrome
Risk of Diabetes in Young Turner Syndrome Patients
Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes.
- Trial name
- NCT02160717
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Obesity, Insulin Resistance
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models).
- Conditions
- Obesity, Insulin Resistance, Insulin Sensitivity, Prediabetes
- Trial name
- NCT01972113
- Testing
- Low-Dose Vitamin K2 (menaquinone-7; 45 mcg/d), High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Augusta University
Type 1 Diabetes Mellitus, New-onset Type 1 Diabetes Mellitus
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the…
- Conditions
- Type 1 Diabetes Mellitus, New-onset Type 1 Diabetes Mellitus, T1DM, T1D
- Trial name
- EXTEND (NCT02293837)
- Testing
- Tocilizumab (TCZ), Standard of Care
- Where
- 19 sites in United States, Australia
- Volunteers
- 136 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes, Diabetes Mellitus, Type 1
Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes
The goal of this clinical trial is to test whether the combination of two safe immune therapies called abatacept and nasal insulin can preserve pancreas function in recently-diagnosed type 1 diabetes.
- Trial name
- IAA (NCT05742243)
- Testing
- Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®)
- Where
- 6 sites in Australia
- Volunteers
- 68 people
- Sponsor
- Melbourne Health
Diabetes Mellitus, Type 1
A Research Trial of Aralast in New Onset Diabetes (RETAIN)
The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to…
- Trial name
- RETAIN (NCT01183468)
- Testing
- Aralast NP 45 mg dose, Aralast NP 90 mg dose, Aralast NP 180 mg dose
- Where
- 15 sites in United States
- Volunteers
- 17 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes
Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Sanford Research/USD proposes to study the combination therapy of oral administration of sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells still present in patients with recent-onset…
- Trial name
- REPAIR-T1D (NCT01155284)
- Testing
- Sitagliptin and Lansoprazole
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Sanford Health
Diabetes Mellitus, Type 1
Probiotics in Newly Recognized Type 1 Diabetes
They are major genera of bacteria that make up the colon flora in human, constitute intestinal microbial homeostasis, inhibit growth of pathogens, improve the gut mucosal barrier and modulate local and systemic immune responses.
- Trial name
- NCT03032354
- Testing
- Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12
- Volunteers
- 96 people
- Sponsor
- Medical University of Warsaw
Cystic Fibrosis
Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis
This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose regulation.
- Trial name
- NCT01721382
- Testing
- Sitagliptin
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Nemours Children's Clinic
Pseudohypoparathyroidism and Pseudopseudohypoparathyroidism, Pseudohypoparathyroidism Type Ia
Glucose Homeostasis in Pseudohypoparathyroidism
It is increasingly recognized that Pseudohypoparathyroidism type 1A (PHP1A) is associated with an increased risk of type 2 diabetes but the mechanism is unknown.
- Conditions
- Pseudohypoparathyroidism and Pseudopseudohypoparathyroidism, Pseudohypoparathyroidism Type Ia, Albright Hereditary Osteodystrophy
- Trial name
- NCT03761290
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Vanderbilt University Medical Center
Diabetes Mellitus, Type 1
A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II
Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug to be tested in this clinical trial.
- Trial name
- RETAIN (NCT01183455)
- Testing
- Aralast NP
- Where
- 15 sites in United States
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Obesity, Childhood, Type 2 Diabetes Mellitus in Obese
Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function
The investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism.
- Trial name
- NCT06682481
- Testing
- Measurement of biomarker
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- Philippe Klee, MD-PhD
Type 1 Diabetes
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain…
- Trial name
- NCT04114357
- Testing
- Acetylated and Butyrylated High Amylose Maize Starch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Indiana University
Type 1 Diabetes
Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.
- Trial name
- NCT01280682
- Testing
- rituximab
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Yang Tao
Prediabetes, Type 1 Diabetes
TEFA Family Prevention: Glutenfree Diet to Preserve Beta-cell Function
To evaluate the effect of Gluten Free Diet (GFD) on beta-cell function and glucose metabolism in subjects with one or several islet autoantibodies without and with dysglycemia at baseline.
- Trial name
- TEFA (NCT02605148)
- Testing
- Gluten free diet, Omega 3 fatty acid, Vitamin D
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Lund University
Type1 Diabetes Mellitus
BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed Type 1 Diabetes Mellitus (T1DM)
- Trial name
- NCT04102202
- Testing
- BOL-DP-o-05
- Sponsor
- Breath of Life International Pharma Ltd
Diabetes Mellitus
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive.
- Trial name
- ktpump (NCT00574405)
- Testing
- MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]), CSII (Animas Corporation insulin pump, model IR 1200)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Arkansas Children's Hospital Research Institute