Increased Insulin Clinical Trial
Official title:
The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR in Normal and Prediabetes Subject
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.
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.
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