Nutritional, Metabolic, Endocrine
Conditions
Interventions
Placebo
Intervention Group
Low dose PhAM
High dose PhAM
Sponsors
Imo State University Owerri
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The main inclusion criteria were: - Age between = 40 years = 75 years - Clinical diagnosis of T2D - On the spot HbA1c >6.5% - History of good compliance to first-line diabetes medications - History of diabetes >2 years.
Exclusion criteria
Exclusion criteria: Smoking, pregnancy, breastfeeding, use of steroids or any immunosuppressive or immunomodulatory therapies, use of any herbal drugs within 2 months before trial commences, history of any other metabolic disease that complicates the pathological features of type 2 diabetes, active hepatitis b or c, HIV, tuberculosis, and systemic infections. - Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants - History of chronic pancreatitis or idiopathic acute pancreatitis - Chronic malabsorption, regardless of etiology - History of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease - Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We are adopting two primary endpoints. The change from baseline to end of treatment (i.e., after 6 months of treatment) in both fasting blood glucose and glycated hemoglobin levels, HbA1C. Subjects who, after 16 weeks of treatment, achieve (yes/no) HbA1c <7% (53 mmol/mol) and less than 120 mg/dl fasting blood glucose levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in incretin levels; glucagon-like peptide (GLP-1), and glucose insulinotropic polypeptide (GIP) levels from baseline compared to levels at the end of the intervention. - Changes in glucagon, C-peptide, and fasting insulin levels from baseline compared to levels at the end of the intervention. - Changes in beta-cell function (homeostatic model assessment index of beta-cell function (HOMA-B) from baseline compared to levels at the end of the intervention. - Changes in body mass index (BMI), blood pressure, mid-arm circumference, and polyuria. | — |
Countries
Nigeria
Contacts
Public ContactPeter Uchenna Amadi
Lecturer Imo State University Owerri
Outcome results
None listed