The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR in Normal and Prediabetes Subject
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- GLP-1
Study Overview
Brief Summary
Prevalence of type 2 diabetes have been increased, but medications had not been well, so that needed new alternatives. A new approach used in management of type 2 diabetes is incretin based therapy. Incretin hormone, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotrophic peptide (GIP), had producted in intestine due to carbohydrate intralumen. After had secreted, GLP-1 had degradated by DPP-4 enzyme till number and effect had been decreased. Decreasing of GLP-1 effect as main defect in type 2 diabetes.
Andrographis paniculata (A. paniculata) as traditional treatment had known since years ago to have hypoglycemia effect. Extract of A. paniculata consists of andrographolid and flavonoid. Based on study of Wooten et al that flavonoid has hydroxyl to stimulate insulin's production through modulated GLP-1 receptor (GLP-1 receptor ligand). So the investigators need to study about The Effect of A. paniculata Extract to GLP-1, Fasting Plasma Insulin, Insulin concentrations measured during a standardized 2-h OGTT, and HOMA-IR.
Detailed Description
Blood's participants will be examined fasting plasma insulin and glycated albumin (from fasting blood) and insulin measured during a standardized 2-h OGTT, DPP-4 enzyme, and GLP-1 (from standardized 2-h OGTT blood). Then, complete urinalysis test. Participants will be randomized to be two groups are group have been intervenced by capsules of A. paniculata or group placebo. Each group will be explained about procedure to consume capsules A. paniculata or placebo for 14 days, storage procedures, and the way to contact the investigators if adverse event happened. The investigators will contact participants to remember the schedule to consume capsules A. paniculata, ask whether the side effects or not, and ask the result of self monitoring blood glucose every three days by glucose meter have been given.
Before day 12th, participants will be contacted to come in visit 2nd. In visit 2nd (day 15th) will be done anamneses, assessment of compliance, reporting adverse event and side effect, physical examination, fasting plasma glucose test, fasting insulin, HOMA-IR, GA and complete urinalysis. Then, will be done standardized 2-h OGTT. Two hours later, it will be done plasma glucose level, insulin, DPP-4 enzyme, and GLP-1. Participants will be explained that they will not receive capsules of A. paniculata for 7 days (day 15th till 21th). This is called wash out.
Participants will be explained about procedures to consume capsule of A. paniculata or placebo in day 22th till 35th. Before day 32th, participants will be contacted to come in visit 3rd (day 36th). In visit 3rd, will be done anamneses, assessment of compliance, reporting adverse event and side effect, physical examination, fasting plasma glucose test, fasting insulin, HOMA-IR, GA and complete urinalysis. Then, will be done standardized 2-h OGTT. Two hours later, it will be done plasma glucose level, insulin, DPP-4 enzyme, and GLP-1.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double Blind
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 year old until 60 year old
- •Normal glucose tolerance subject or prediabetes
- •The kidney function (creatinine) and liver function (SGPT) in range normal
- •Subject has signed agreement (informed consent)
Exclusion Criteria
- •Feeding baby
- •Subject has comorbide or chronic disease uncontrolled
- •Subject has cancer
- •Subject consume medication influenced blood glucose such as steroid an suplement
- •Insulin dependent diabetes
Arms & Interventions
Normal subject experimental
Participants get Andrographis Paniculata Extract 550 mg, two capsules, twice a day, for 14 days.
Intervention: Andrographis Paniculata Ext (Other)
Normal subject placebo
Participants get placebo consist of Lactose 98%, Mg 2%, two capsules, twice a day, for 14 days.
Intervention: Andrographis Paniculata Ext (Other)
Prediabetes subject experimental
Participants get Andrographis Paniculata Extract 550 mg, two capsules, twice a day, for 14 days.
Intervention: Andrographis Paniculata Ext (Other)
Prediabetes subject placebo
Participants get placebo consist of Lactose 98%, Mg 2%, two capsules, twice a day, for 14 days.
Intervention: Andrographis Paniculata Ext (Other)
Outcomes
Primary Outcomes
GLP-1
Time Frame: A measure assesing change from baseline GLP-1 at 14 days.
Index analyzes incretin effect
Secondary Outcomes
- Dypeptidil Peptidase 4 (DPP-4) Enzyme(A measure assesing change from baseline GLP-1 at 14 days.)
- Glycated Albumin(A measure assesing change from baseline GLP-1 at 14 days.)
- 2h-OGTT Insulin(A measure assesing change from baseline GLP-1 at 14 days.)
- HOMA-IR(A measure assesing change from baseline GLP-1 at 14 days.)
- Fasting plasma glucose level(A measure assesing change from baseline GLP-1 at 14 days.)
- Fasting Insulin(A measure assesing change from baseline GLP-1 at 14 days.)
- 2h-OGTT plasma glucose level(A measure assesing change from baseline GLP-1 at 14 days.)
Investigators
Dr Tri Juli Edi Tarigan, SpPD-KEMD
MD, Endocrinologist
Indonesia University