Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT03356457
Eligibility Criteria:
Inclusion Criteria:
Group 1:
* Diagnosed C-peptide-negative T1DM, \> 5 years duration, HbA1c of \< 7.5%
* Intensive management, defined by frequent self-monitoring of glucose values and by the administration of 3 or more insulin injections each day (or the use of insulin pump therapy).
* History of severe hypoglycemia and hypoglycemia unawareness as assessed by the Guy's and Thomas' Minimally Modified Clarke Hypoglycemia Survey, the Gold Score and the Edinburgh Hypoglycemia Survey (see Appendix 1)
* Willingness to fast and to reduce insulin therapy for a limited time period
Group 2:
* Age, weight, and gender matched to group 1 subjects
* HbA1c \<6%
* Good general health as evidenced by medical history and blood screening
* Willing to fast for a limited time period
Exclusion Criteria:
General criteria:
* Known allergic reactions to components of the study product(s)
* Participants carrying polymorphisms known to slow DCA metabolism (e.g. KGM or EGM allele \[10\])
* Treatment with another investigational drug or other intervention
* Active infection including hepatitis C, hepatitis B, HIV
* Any past or current history of alcohol or substance abuse
* Psychiatric or neurological disorders, including need for medications, including anxiolytics, and antidepressants
* Baseline Hgb \< 10.5 g/dL in females, or \< 12.5 g/dL in males. Blood donation within 30 days of the study
* History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
* Co-existing cardiac, liver, and kidney disease
* Abnormal liver function tests
* GI disorders potentially interfering with the ability to absorb oral medications
* Women that are post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
* Any medical condition that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
* Any medication assumed less than 30 days before the study sessions that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes.The list of medications to be avoided includes - but is not limited to - drugs known to influence metabolic and endocrine function (other than insulin in Group 1) and neuroactive medications.
Group 1:
* Detectable C-peptide;
* Untreated proliferative retinopathy;
* Creatinine ≥1.5 mg/dl, urinary albumin levels . 300 mg/day
* Autonomic neuropathy; painful peripheral neuropathy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03356457
Study Brief:
Protocol Section:
NCT03356457