The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR
Condition: Increased Insulin
MeSH terms: Hyperinsulinism
Study type: Interventional

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.
    

Intervention name(s): Andrographis Paniculata Ext
Intervention type(s): Other
Intervention description(s): Give the Androgaphis paniculata in prediabetes and normal subject for 14 days.
Intervention MeSH terms: Andrographolide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Clinical Trials with Randomization, Double Blind, Crossover
Masking: Double (Participant, Investigator)
Primary purpose: Treatment