Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.

Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia. - Clinical trial of high-dose vitamin B12 treatment for type 1 diabetic patients with impaired awareness of hypoglycemia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026348

Enrollment

Registered

2017-03-31

Start date

2017-03-31

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

type 1 diabetes

Interventions

Vitamin B12 intramuscularly injection 1mg per day for 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Type 1 diabetes(Eligible participants had a known history of type 1 diabetes for at least 6 months, and had been treated for at least 6 months with a basal-bolus insulin regimen) 2)Treatment with multiple insulin injection 3)Hypoglycemia unawareness 4)Autonomic dysfunction

Exclusion criteria

Exclusion criteria: 1)Patients younger than 19 years old. 2)Severe liver dysfunction 3)Severe renal failure 4)Pregnant 5)Angina pectoris,epilepsy,preproliferative diabetic retinopathy(PPDR) and proliferative diabetic retinopathy(PDR) 6)Judged as ineligible by clinical investigators

Design outcomes

Primary

Measure	Time frame
Symptoms of hypoglycemia in an insulin tolerance test(Day 21~28)).	—

Secondary

Measure	Time frame
Autonomic function(coefficient of variation of R-R interval, Schellong test) Epinephrine, norepinephrine, dopamine, cortisol, ACTH, growth hormone, glucagon	—

Countries

Japan

Contacts

Public ContactShingo Fujita

Graduate School of Medicine, Osaka University Department of Metabolic Medicine

lutefs222@endmet.med.osaka-u.ac.jp06-6879-3732

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026