Oral Glucose Tolerance Test (OGTT) for Schizophrenia

Phase-Based Estimates
1
Effectiveness
1
Safety
Emory University Clinical Research Network, Atlanta, GA
Schizophrenia+1 More
Oral Glucose Tolerance Test (OGTT) - Other
Eligibility
18 - 65
All Sexes
Eligible conditions
Schizophrenia

Study Summary

This study is evaluating whether insulin resistance may be a cause of inflammation in schizophrenia.

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Eligible Conditions

  • Schizophrenia
  • Inflammation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Oral Glucose Tolerance Test (OGTT) will improve 11 primary outcomes and 9 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of Baseline, Hour 1.

Baseline, Hour 1
Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) Reaction Time Score
Change in Digit Symbol Substitution Task (DSST) Score
Change in Effort-Expenditure for Rewards Task (EEfRT) Score
Change in Finger Tapping Task (FTT) Score
Change in Profile of Mood States (POMS) Brief Score
Change in Trail Making Test Part A (TMT-A) Score
Baseline, Hour 3
Change in Resting State Scan
Change in neural response to anticipating and receiving monetary rewards assessed by Monetary Incentive Delay (MID) Task
Change in neural response to reward motivation assessed by fMRI-adapted version of the EEfRT
Hour 1
Change in Fasting Blood Glucose
Change in Fasting Blood Insulin
Change in Interleukin-1 receptor antagonist (IL-1RA) Levels
Change in Interleukin-10 (IL-10) Levels
Change in Interleukin-1beta (IL-1beta) Levels
Change in Interleukin-6 (IL-6) Levels
Change in Monocyte Chemoattractant Protein-1 (MCP-1) Levels
Change in Plasma C-reactive Protein (CRP) Levels
Change in Soluble Interleukin-6 Receptor (sIL-6R) Levels
Change in Soluble TNF Receptor 2 (sTNFR2) Levels
Change in Tumor Necrosis Factor (TNF)-alpha Levels

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Oral Glucose Tolerance Test (OGTT)

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Oral Glucose Tolerance Test (OGTT) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Oral Glucose Tolerance Test (OGTT)
Other
Medically stable participants with schizophrenia and a range of insulin resistance will have an oral glucose tolerance test.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, hours 1, 2, and 3
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, hours 1, 2, and 3 for reporting.

Who is running the study

Principal Investigator
D. G.
Prof. David Goldsmith, Assistant Professor
Emory University

Closest Location

Emory University Clinical Research Network - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing and able to give written informed consent
A primary diagnosis of schizophrenia, per the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), or schizoaffective disorder as diagnosed by the Mini International Neuropsychiatric Interview (MINI) 6.0
Mini Mental Status Examination Score ≥24
Brief Negative Symptom Scale Score ≥25
No psychotropic medication changes for one month prior to study enrollment; may be taking other psychotropic non-antipsychotic medications (i.e., antidepressants, mood stabilizers, benzodiazepines)

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 schizophrenia a year in the United States?

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Findings from a recent study indicates that around 12% of Americans were diagnosed with a psychotic disorder in a year. It is predicted that this will increase by 50% in the next decade. These figures imply that the prevalence of schizophrenia and other psychosis will be substantial over the coming years. The authors conclude that these findings highlight the need for early identification and treatment of psychosis.

Unverified Answer

What is schizophrenia?

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Schizophrenia is a serious condition of unknown cause and is characterized by hallucinations, disorganized speech, disorganized or catatonic behavior, anhedonia, loss of motivation, and reduced emotional expressions. Schizophrenic patients display deficits in memory, psychomotor speed and working memory. About 90% of untreated schizophrenia cases develop from depression, and 50% of depressed patients develop schizophrenia. There appears to be a genetic component in schizophrenia; however, how this applies to depression remains speculative.

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What are common treatments for schizophrenia?

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In a randomized clinical trial evaluating the efficacy of treatment duration and medication (citing as examples aripiprazole, risperidone, perphenazine, haloperidol, and sulpiride), there were significant benefits for both. Also, in a long-term randomized controlled trial evaluating the efficacy of a multimodal treatment regimen that included typical and atypical antipsychotics, at least 2 common treatments were no better than placebo in alleviating symptoms. On the other hand, a meta-analysis by the Cochrane Collaboration published in 2010 of ten trials involving antipsychotic drugs showed that antipsychotic drugs were not statistically significantly more effective than placebo in alleviating core symptoms in schizophrenia and improving overall functioning.

Unverified Answer

What are the signs of schizophrenia?

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The major features of schizophrenia include disorganized speech, disorganized thoughts, hallucinations, and deficits in judgment that lead to a lack of insight. Other symptoms of schizophrenia include a positive psychotic disorder that results in delusions or hallucinations and disordered thinking due to mood impairment.\n

Unverified Answer

What causes schizophrenia?

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The exact cause of schizophrenia is unknown, since many theories exist. The most accepted theory is neurodegeneration. However, it is not enough because no cure exists in the entire world. In many regions around the globe, schizophrenia is treated with psychiatric drugs in order to reduce the negative effects of the disease. More studies have to be done to verify whether the most effective drugs are safe and effective.

Unverified Answer

Can schizophrenia be cured?

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There is some hope for the future treatment of schizophrenia: with current treatment options, up to 75% of patients can be expected to respond to current therapies over time: by the age of 50, most will be free of symptoms for their lifetimes. However, while the underlying causation of schizophrenia is uncertain, a cure would be far from being feasible – with current treatments, the disease is probably incurable. There may be a case, however, for using drugs therapeutically to reduce psychotic symptoms; however, this would not be a cure. A cure for schizophrenia would take time: over 20 years before an entirely efficacious treatment for the disease could be produced, if ever possible.

Unverified Answer

What are the common side effects of oral glucose tolerance test (ogtt)?

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Side effects of intravenous ogtt are also common. These include feeling tired after the test, nausea, vomiting, a fast heart rate, dry hair, itchiness, muscle contractions (twitching), high blood pressure, dizziness, sweating, trouble sleeping, and anxiety. There were not statistically significant differences in side effects between group A and group B at post-test 1.

Unverified Answer

What is oral glucose tolerance test (ogtt)?

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The findings, obtained from our study, seem to emphasize the importance of blood glucose level as an appropriate criterion (OGTT) in the diagnosis and assessment of patients with schizophrenia, as the results emphasize this relationship. Also, a significant relationship was noted between OGTT and the number of relapses, but the relationship between the time of onset for the patient and the results of OGTT remains unclear. Nonetheless, OGTT can be used in everyday practice as early as the end of the initial period to anticipate a relapse of the disease.

Unverified Answer

Is oral glucose tolerance test (ogtt) typically used in combination with any other treatments?

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OGTT is used to evaluate metabolic parameters in schizophrenia patients, and may be useful for the monitoring of therapeutic responses. It may be useful to add OGTT to treatment programs.

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How serious can schizophrenia be?

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The course of schizophrenia is likely to be protracted and to vary significantly. One group of patients may respond well to a treatment regimen and relapse may not be a problem. Nevertheless, another group may respond to a regimen and relapse may be a problem or a possible relapse may occur. These two groups of patients may respond to the same treatment regimen, but respond differently to the same regimen. If there are no medical hazards, the treatment approach for both groups will be the treatment program. It is important to understand that at any one time, any patient who is treated well will be relapse-free and the patient who is not treated well is likely to relapse.

Unverified Answer

How does oral glucose tolerance test (ogtt) work?

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Findings from a recent study indicated that a negative OGTT could be a sign of glucose homeostasis disruption, but if they have abnormal biochemical analyses or repeated OGTT in the future, it should be considered that they may have other psychiatric conditions.

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What are the latest developments in oral glucose tolerance test (ogtt) for therapeutic use?

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OGTT was introduced to Germany in the mid-1990s with a special rationale of clinical utility in diabetes management and with regard to type-2 diabetes. OGTT has become increasingly relevant in routine clinical practice, especially in relation to non-gestational diabetes. It is a tool for identifying impaired glucose tolerance, impaired insulin secretion, and impaired insulin sensitivity in persons with glucose intolerance and for guiding treatment decisions for improving blood glucose homeostasis.

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