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Completed

NCT Number: NCT03455049

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Pregnant
  • 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

Treatment and study plan

Andrographis Paniculata Ext

Other

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

Primary outcomes

  1. GLP-1

    Time frame: A measure assesing change from baseline GLP-1 at 14 days.

    Index analyzes incretin effect

Secondary outcomes

  1. Fasting Insulin

    Time frame: A measure assesing change from baseline GLP-1 at 14 days.

    Index analyzes beta-cell secretion

  2. 2h-OGTT Insulin

    Time frame: A measure assesing change from baseline GLP-1 at 14 days.

    Index analyzes beta-cell secretion after 2h-OGTT

  3. HOMA-IR

    Time frame: A measure assesing change from baseline GLP-1 at 14 days.

    Index of insulin resistance

  4. Fasting plasma glucose level

    Time frame: A measure assesing change from baseline GLP-1 at 14 days.

    Index analyzes beta-cell function

  5. 2h-OGTT plasma glucose level

    Time frame: A measure assesing change from baseline GLP-1 at 14 days.

    Index analyzes beta-cell function after 2h-OGTT

  6. Dypeptidil Peptidase 4 (DPP-4) Enzyme

    Time frame: A measure assesing change from baseline GLP-1 at 14 days.

    Index analyzes degradation of GLP-1 in Ileum

  7. Glycated Albumin

    Time frame: A measure assesing change from baseline GLP-1 at 14 days.

    Index analyzes plasma glucose during 2 weeks

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2018
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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