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The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR

The Effect of Andrographis Paniculata to GLP-1, Fasting Insulin, Insulin 2-h Post OGTT, and HOMA-IR in Normal and Prediabetes Subject

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03455049
Enrollment
73
Registered
2018-03-06
Start date
2017-10-17
Completion date
2018-05-02
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Increased Insulin

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.

Interventions

OTHERAndrographis Paniculata Ext

Give the Androgaphis paniculata in prediabetes and normal subject for 14 days.

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double Blind

Intervention model description

Clinical Trials with Randomization, Double Blind, Crossover

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18 year old until 60 year old 2. Normal glucose tolerance subject or prediabetes 3. The kidney function (creatinine) and liver function (SGPT) in range normal 4. Subject has signed agreement (informed consent)

Exclusion criteria

1. Pregnant 2. Feeding baby 3. Subject has comorbide or chronic disease uncontrolled 4. Subject has cancer 5. Subject consume medication influenced blood glucose such as steroid an suplement 6. Insulin dependent diabetes

Design outcomes

Primary

MeasureTime frameDescription
GLP-1A measure assesing change from baseline GLP-1 at 14 days.Index analyzes incretin effect

Secondary

MeasureTime frameDescription
2h-OGTT InsulinA measure assesing change from baseline GLP-1 at 14 days.Index analyzes beta-cell secretion after 2h-OGTT
HOMA-IRA measure assesing change from baseline GLP-1 at 14 days.Index of insulin resistance
Fasting plasma glucose levelA measure assesing change from baseline GLP-1 at 14 days.Index analyzes beta-cell function
Fasting InsulinA measure assesing change from baseline GLP-1 at 14 days.Index analyzes beta-cell secretion
Dypeptidil Peptidase 4 (DPP-4) EnzymeA measure assesing change from baseline GLP-1 at 14 days.Index analyzes degradation of GLP-1 in Ileum
Glycated AlbuminA measure assesing change from baseline GLP-1 at 14 days.Index analyzes plasma glucose during 2 weeks
2h-OGTT plasma glucose levelA measure assesing change from baseline GLP-1 at 14 days.Index analyzes beta-cell function after 2h-OGTT

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026