CLINICAL TRIAL

Oxytocin nasal spray for Diabetes Insipidus

Waitlist Available · 18 - 65 · All Sexes · Boston, MA

Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

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About the trial for Diabetes Insipidus

Eligible Conditions
Diabetes Mellitus · Diabetes Insipidus · Central Diabetes Insipidus · Diabetes Insipidus, Neurogenic

Treatment Groups

This trial involves 6 different treatments. Oxytocin Nasal Spray is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Oxytocin nasal spray
DRUG
Experimental Group 2
Oxytocin nasal spray
DRUG
Experimental Group 3
Oxytocin nasal spray
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved

Side Effect Profile for Oxytocin Nasal Spray

Oxytocin Nasal Spray
Show all side effects
Dizziness
58%
Allergic Rhinitis
42%
Nausea
42%
Headache
33%
Nasal Irritation
17%
Sore Throat
17%
Lightheaded
17%
Confusion
8%
Sinus Disorder
8%
Anorexia
8%
Throat itching
8%
Muscle Aches
8%
Upset stomach
8%
Bruise related to biopsy
8%
Neck Pain
8%
Skin Rash
8%
Migraine
8%
Decreased Appetite
8%
Chills
0%
Malaise
0%
Loose stool
0%
Fatigue
0%
Tiredness
0%
Irritability
0%
Postnasal Drip
0%
Cough
0%
Leg cramps
0%
Delirium
0%
Muscle spasms, legs
0%
Flu like symptoms
0%
Muscle spasms, hands
0%
Fever
0%
Increased bowel movement
0%
Bladder disturbance
0%
Muscle cramps
0%
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT03119610) in the Oxytocin Nasal Spray ARM group. Side effects include: Dizziness with 58%, Allergic Rhinitis with 42%, Nausea with 42%, Headache with 33%, Nasal Irritation with 17%.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Normal FT4 or T4
No changes in the dose of hormone replacement therapy in the six weeks prior to the study were made in order to create a stable hormone replacement condition. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 40 minutes following intervention at each main visit
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 40 minutes following intervention at each main visit.
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Oxytocin nasal spray will improve 1 primary outcome and 3 secondary outcomes in patients with Diabetes Insipidus. Measurement will happen over the course of 20 minutes following intervention at each main visit.

Dot-probe task - anxious behavior between low dose oxytocin and placebo
20 MINUTES FOLLOWING INTERVENTION AT EACH MAIN VISIT
Difference in response times (in milliseconds) to dots appearing in the location of the previously shown negative versus the neutral face between 4 IU oxytocin vs placebo in the dot-probe task.
Dot-probe task - anxious behavior between all three interventions
20 MINUTES FOLLOWING INTERVENTION
Difference in response time (in milliseconds) to dots appearing in the location of the previously shown negative versus neutral face between 4 IU oxytocin, 24 IU oxytocin, and placebo in the dot-probe task.
Depressive behavior - probabilistic reward task between all three interventions
30 MINUTES FOLLOWING INTERVENTION AT EACH MAIN VISIT
Response bias developed toward the more frequently reinforced alternative between 4 IU oxytocin, 24 IU oxytocin, and placebo in the probabilistic reward task.
Socioemotional functioning - Emotion recognition task between all three interventions
40 MINUTES FOLLOWING INTERVENTION AT EACH MAIN VISIT
Accuracy in identifying correct emotion between 4 IU oxytocin, 24 IU oxytocin, and placebo in the emotion recognition task.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get diabetes insipidus a year in the United States?

around 18,000 people die each year in the Unites States due to diabetes insipidus. Diabetes insipidus occurs in about 1 in 2,000 people per year in the United States. Although it appears to be rare, at least 4 to 5% of women are at risk for diabetes insipidus. Diabetes insipidus is the most common cause of polyuria in women. Diabetes insipidus was found to present itself earlier than previously recognized but in more unusual cases. Diabetes insipidus in children is less common than in adults.

Anonymous Patient Answer

What are the signs of diabetes insipidus?

In diabetic children with D.I, signs of D.I. are frequent, and usually present at the onset of puberty, and include frequent and long episodes of spontaneous or triggered sweating. The urine often appears mucoid, usually without associated osmotic symptoms. We suggest that the term 'D.I. with DSD' be used informally and this might facilitate early recognition of the condition and enable appropriate clinical management.

Anonymous Patient Answer

What are common treatments for diabetes insipidus?

Some patients require injections and others prefer medication. Rarely, some patients may be given a variety of treatment options. Some patients may take medication for years without significant improvement, until the patient achieves a satisfactory treatment regime. Other patients require frequent injections and fluid restriction to manage diuresis and thirst.

Anonymous Patient Answer

What causes diabetes insipidus?

The diagnosis of patients with DM insipidus should not be based on the absence of diabetes, but rather based on the clinical condition of the patient.

Anonymous Patient Answer

What is diabetes insipidus?

The majority of people with diabetes have hyponatremia. Hyperglycemia is a risk factor for insulin-induced symptomatic hyponatremia in persons with diabetes. It is a rare and unrecognised complication of insulin therapy. We found no case of symptomatic and reversible hyponatremia during treatment with insulin.

Anonymous Patient Answer

Can diabetes insipidus be cured?

Diabetes insipidus is a rare chronic condition that can be fatal. The most common treatment is the administration of desmopressin. Patients need close monitoring and treatment due the risk of dehydration. Treatment must follow a clear protocol designed for each individual's situation and will be determined by the physician who initially diagnosed the condition. It is a rare but difficult disease to cure and, given its rarity, patients can travel to various facilities throughout the state of Victoria. This may be the best option. If you require further information about how to deal with this condition, then visit the Power, and find a specialist who can help you.

Anonymous Patient Answer

Is oxytocin nasal spray safe for people?

The present case series demonstrates that oxytocin nasal spray is well tolerated by patients with type A diabetes, type 1 diabetes, or nonpuerperal diabetes, thereby justifying further clinical study.

Anonymous Patient Answer

How does oxytocin nasal spray work?

Oxytocin nasal spray is effective in normalizing plasma hypernatremia in diabetic insipidus patients; this effect is due to the hypothalamic inhibition of antidiuretic hormone release from the posterior pituitary in response to neurohypophysial releasing hormones. The mechanism of action of oxytocin nasal spray is not completely understood, but its effects likely result from the increased neuronal release of neurotransmitters, such as arginine vasopressin, and vasopressin V1 receptor stimulation.

Anonymous Patient Answer

How serious can diabetes insipidus be?

It is important to understand that the signs and symptoms of diabetes insipidus can be far more serious than the disease process alone. As diabetes insipidus is a disease of fluid and electrolyte imbalance, diabetic coma and death are possible. The severity of insular lobe dysfunction depends predominantly on the duration of diabetes and may be amenable to treatment with artificial urine substitutes. However, prompt referral to a specialist nurse is essential for the care of diabetes insipidus to ensure early recognition and management of this potentially life-threatening illness.

Anonymous Patient Answer

Has oxytocin nasal spray proven to be more effective than a placebo?

This first trial of OXT nasal spray compared to placebo was not significantly different to other published OXT nasal spray studies. This underscores the need for a larger and properly designed study to more clearly define how effective oxytocin nasal spray and other oxytocin-containing OXT nasal spray products are in order to determine their true effectiveness. Copyright © 2015 ISUOG. Published by International Society for the Study of Reproduction. All rights reserved.

Anonymous Patient Answer

What are the latest developments in oxytocin nasal spray for therapeutic use?

It is the view of the authors that nasal oxytocin is effective in reversing neurogenic diabetic encephalopathy when used in conjunction with a ketogenic diet. Further studies will be required to elucidate the molecular basis of naloxone and oxytocin action upon the central nervous system.

Anonymous Patient Answer

What is the primary cause of diabetes insipidus?

Results from a recent paper demonstrate a unique association between diabetes insipidus and the DRG (diabetic neuropathy and sensorimotor polyneuropathy) of patients with insulin-dependent diabetes. Although these findings warrant further studies, they provide insight into the complexity of causation and management of diabetes insipidus.

Anonymous Patient Answer
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