Latent Autoimmune Diabetes in Adults: Background, Safety and Feasibility of an Ongoing Pilot Study With Intra-Lymphatic Injections of GAD-Alum and Oral Vitamin D.

What Was Tested

Researchers studied Vitamin D, K2, Magnesium and Zinc in this clinical trial publication.

These findings prompted them to evaluate a treatment that directly affects autoimmunity.

Primary objective is to evaluate safety and feasibility.

Why It Was Studied

Many LADA patients gradually lose their insulin secretion and progress to insulin dependency.

In a recent trial BALAD (Behandling Av LADa) early insulin treatment compared with sitagliptin failed to preserve insulin secretion, which deteriorated in individuals displaying high levels of antibodies to GAD (GADA).

Who Took Part

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults.

Fourteen GADA-positive (>190 RU/ml), insulin-independent patients 30-70 years old, with LADA diagnosed within < 36 months were included in an open-label feasibility trial.

Results will be compared with those of the recent BALAD study with comparable patient population.

How the Study Was Run

In design terms this was an open-label and pilot study.

Everyone knew when Vitamin D, K2, Magnesium and Zinc was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It is described as a pilot, a small early test of whether a larger Vitamin D, K2, Magnesium and Zinc study would be practical.

Mixed Meal Tolerance Test and i.v.

Glucagon Stimulation Test at baseline and after 5 and 12 months are used for estimation of beta cell function.

What Was Measured

In a recent trial BALAD (Behandling Av LADa) early insulin treatment compared with sitagliptin failed to preserve insulin secretion, which deteriorated in individuals displaying high levels of antibodies to GAD (GADA).

The researchers therefore tested the feasibility of such therapy in LADA-patients (the GADinLADA pilot study).

The subject headings attached to it are Alum Compounds, Diabetes Mellitus, Type 1, Feasibility Studies, Glucose Intolerance, Glutamate Decarboxylase, Insulin and Latent Autoimmune Diabetes in Adults.

Author keywords: (LADA), GADalum, antigen-specific immunotherapy, intra-lymphatic and vitamin D.

What This Means in Plain Language

The paper is an open-label and pilot study of Vitamin D, K2, Magnesium and Zinc.

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2022 (Frontiers in endocrinology), a journal based in Switzerland.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.