Stimulated serum C-peptide after a mixed-meal tolerance test

What acts on it

1. We studied 334 patients aged 10 to 20 years with type 1 diabetes, fasting C-peptide levels of more than 0.3 nanograms per millilitre and detectable serum GAD65 autoantibodies, randomly assigned within 3 months after diagnosis to four doses of GAD-alum, two doses followed by two doses of placebo, or four doses of placebo, the stimulated C-peptide level declined to a similar degree in all study groups and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group with P = 0.10, and the use of GAD-alum did not affect the insulin dose, glycated haemoglobin level or hypoglycaemia rate.

   Alum-formulated GAD65 antigen therapy → Stimulated serum C-peptide after a mixed-meal tolerance test source_derived_draftungraded
   Experimental context and source evidence

   evidence_span

   {"source_cache": "artifacts/gaba-research/22296077.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "fc3bf9a083b3179c8573e993fb61f09412eca7890c3ccfb3ba5b8c0fb26acce8", "start_char": 0, "end_char": 1683, "text_sha256": "fc3bf9a083b3179c8573e993fb61f09412eca7890c3ccfb3ba5b8c0fb26acce8"}

   experimental_model

   Randomised placebo-controlled trial of an alum-formulated autoantigen in 334 patients within three months of diagnosis

   exposure

   Four doses of GAD-alum, two doses followed by placebo, or four doses of placebo, in patients aged 10 to 20 with detectable GAD65 autoantibodies

   limitations

   A properly powered randomised trial with stimulated C-peptide as the primary outcome. It tests the autoantigen as a therapy, not GABA.

   nutrient_topic

   GABA research collection; topical membership is not evidence of a direct clinical effect, and the sign of a GABA response depends on the chloride gradient of the cell it was measured in. · Gamma-aminobutyric acid

   organism

   Human

   plain_language

   Vaccinating against the enzyme the immune system attacks did not slow the loss of insulin production.

   primary_references

   [gb-p22296077] GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. (2012). https://pubmed.ncbi.nlm.nih.gov/22296077/ DOI: 10.1056/nejmoa1107096

   tissue_or_cell_type

   Pancreatic beta cell function

   GABA: a ligand with no sign of its own, the cofactor that limits its synthesis, the barrier that keeps it out of the brain, and the immune settings where the same molecule protects and harms (2026-09-22) · lines 456–467

   AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text. · supports · Randomised placebo-controlled trial of an alum-formulated autoantigen in 334 patients within three months of diagnosis · source_derived_draft · unverified_draft

   ### gb-targeting-the-autoantigen-did-not-work We studied 334 patients aged 10 to 20 years with type 1 diabetes, fasting C-peptide levels of more than 0.3 nanograms per millilitre and detectable serum GAD65 autoantibodies, randomly assigned within 3 months after diagnosis to four doses of GAD-alum, two doses followed by two doses of placebo, or four doses of placebo, the stimulated C-peptide level declined to a similar degree in all study groups and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group with P = 0.10, and the use of GAD-alum did not affect the insulin dose, glycated haemoglobin level or hypoglycaemia rate. Condition category: normal nutrient_topic: GABA research collection; topical membership is not evidence of a direct clinical effect, and the sign of a GABA response depends on the chloride gradient of the cell it was measured in. plain_language: Vaccinating against the enzyme the immune system attacks did not slow the loss of insulin production. organism: Human tissue_or_cell_type: Pancreatic beta cell function experimental_model: Randomised placebo-controlled trial of an alum-formulated autoantigen in 334 patients within three months of diagnosis limitations: A properly powered randomised trial with stimulated C-peptide as the primary outcome. It tests the autoantigen as a therapy, not GABA. exposure: Four doses of GAD-alum, two doses followed by placebo, or four doses of placebo, in patients aged 10 to 20 with detectable GAD65 autoantibodies evidence_span: {"source_cache": "artifacts/gaba-research/22296077.abstract.txt", "locator": "Indexed abstract; zero-based, end-exclusive Unicode character offsets", "file_sha256": "fc3bf9a083b3179c8573e993fb61f09412eca7890c3ccfb3ba5b8c0fb26acce8", "start_char": 0, "end_char": 1683, "text_sha256": "fc3bf9a083b3179c8573e993fb61f09412eca7890c3ccfb3ba5b8c0fb26acce8"} [gb-p22296077] GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. (2012). https://pubmed.ncbi.nlm.nih.gov/22296077/ DOI: 10.1056/nejmoa1107096

   Complete structured claim and evidence