NCT03410277Completed
Recurrent Hypoglycemia in Type 1 Diabetes (Aim 1)
Measurement of Glucose Homeostasis in Human Brain by NMR: Effect of Recurrent Hypoglycemia on Type 1 Diabetes (Aim 1)
Source: ClinicalTrials.gov · Last updated 3 May 2024
Brief summary (registry, in English)
This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH. Subject glycemic variability for 2 weeks and activity/sleep for 1 week before each study will be monitored as all factors have been shown to alter responses to HG.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 18 Jan 2018
- Start date
- 24 May 2018
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- University of Minnesota
- Diseases
- Type 1 diabetes
- NCT number
- NCT03410277
What you commit to
- Study type: Interventional
- Participants enrolled: 47
- From 24 May 2018 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled hypertension (blood pressure \> 145/95 mmHg at screening)
- Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis)
- History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias
Lab values
- Impaired kidney function (GFR \< 45)
- Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician
Other
- Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires
- Pregnant or plan to become pregnant during the study period
- Proliferative retinopathy
- Current substance abuse
- Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs
Who the study is looking for
- Type 1 diabetes diagnosed on clinical or laboratory grounds
- Diabetes duration 2 - 30 years
- Hemoglobin A1C \<8.5%
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.