CLINICAL TRIAL

Intensification of insulin regimen/Nutrition for Diabetes Mellitus, Type 2

Recruiting · 18 - 65 · All Sexes · New Haven, CT

This study is evaluating whether there are differences in brain glucose transport in individuals with poorly controlled type 2 diabetes.

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About the trial for Diabetes Mellitus, Type 2

Eligible Conditions
Type 2 Diabetes Mellitus · Diabetes Mellitus, Type 2

Treatment Groups

This trial involves 2 different treatments. Intensification Of Insulin Regimen/Nutrition is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Intensification of insulin regimen/Nutrition
BEHAVIORAL
Experimental Group 2
Intensification of insulin regimen/Nutrition
BEHAVIORAL

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Type 2 Diabetics with HbA1c > 7.5% with short duration of diabetes <5 years or Type 2 Diabetics with HbA1c > 7.5% longer duration of diabetes >5 years
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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: 12 Week
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 Week
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 Week.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Intensification of insulin regimen/Nutrition will improve 2 primary outcomes and 8 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of 12 Weeks.

Intracerebral concentrations of glucose between T2DM patients
12 WEEKS
Intracerebral concentrations of glucose will be compared between T2DM patients before and after 12 weeks of intensification of their diabetes management
12 WEEKS
Multitasking Test (MTT)
12 WEEK
The Multitasking Test is a test of the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Outcome measures for the Multitasking Test include response latencies and error scores that reflect the participant's ability to manage multitasking and the interference of incongruent task-irrelevant information on task performance (i.e. a Stroop-like effect).Administration time: 8 minutes
12 WEEK
Rapid Visual Information Processing (RVP)
12 WEEK
Rapid Visual Information Processing is a measure of sustained attention. Outcome measures cover latency (speed of response), probability of false alarms and sensitivity. Administration time: 7 minutes
12 WEEK
Delayed Matching to Sample (DMS)
12 WEEK
Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalizable patterns. Outcome measures include latency (the participant's speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response. Administration time: 7 minutes
12 WEEK
Reaction Time (RTI)
12 WEEK
Reaction Time provides assessments of motor and mental response speeds, as well as measures of movement time, reaction time, response accuracy and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. Administration time: 3 minutes
12 WEEK
Pattern Recognition Memory (PRM)
12 WEEK
Pattern Recognition Memory is a test of visual pattern recognition memory in a 2-choice forced discrimination paradigm.Outcome measures include the number and percentage of correct trials and latency (speed of participant's response). Administration time: 4 minutes
12 WEEK
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Patient Q & A Section

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

What are common treatments for diabetes mellitus, type 2?

Insulation of diabetic people can increase the duration and length of survival, especially if administered before the need for insulin therapy. Insulin is a common drug that improves glucose control, thereby making management of diabetes even more effective.\n

Anonymous Patient Answer

How many people get diabetes mellitus, type 2 a year in the United States?

Approximately 6 million people have [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes), making it the eighth leading cause of death in the United States. Diabetes is the second leading cause of all-cause morbidity and mortality. With the increase of diabetes in the United States and the subsequent increase of diabetes deaths, diabetes will become a major public health issue.

Anonymous Patient Answer

What are the signs of diabetes mellitus, type 2?

Although there may be vague symptoms of diabetes in the early stages of the disease, the major signs of the chronic disease include frequent urination, high blood glucose and chronic headaches.

Anonymous Patient Answer

Can diabetes mellitus, type 2 be cured?

Data from a recent study obtained in our series do not allow one to definitively answer the question as to whether or not this disease could be cured.

Anonymous Patient Answer

What is diabetes mellitus, type 2?

Diabetes mellitus, type 2 is the most common cause of diabetes in the elderly and women. It involves some unusual features such as high blood pressure and increased blood cholesterol. Effective screening and early treatment are essential for better control and prevention of complications.

Anonymous Patient Answer

What causes diabetes mellitus, type 2?

The prevalence of diabetes at baseline was 10%, but it doubled in the first year after a diagnosis of ischemic heart disease or CVD. Patients with diabetes were substantially older, had lower socioeconomic status and more co-morbidities than patients without diabetes. A history of diabetes and obesity were independent predictors of CVD risk in patients with insulin deficiency of the body.

Anonymous Patient Answer

How serious can diabetes mellitus, type 2 be?

Type 2 diabetes-related complications account for a majority of patients who die in hospital and may lead to increased in-hospital resource utilization. Although other causes of mortality are also important, these patients have an increased mortality risk. Recent findings highlights a potential marker for improved long-term mortality prediction.

Anonymous Patient Answer

Is intensification of insulin regimen/nutrition safe for people?

Intensification of insulin regimen/nutrition therapy can be a safe option for frail older adults with type 2 diabetes with poor metabolic control. However, it is necessary to follow up the patients carefully in order to avoid serious health complications.

Anonymous Patient Answer

What are the latest developments in intensification of insulin regimen/nutrition for therapeutic use?

Diabetes is an insulin resistant or insulin sensitive disease associated with changes in the expression of glucose transporter subunits. Since the glycaemic control in diabetes mellitus type 2 depends on factors other than the beta cell function, we believe that the beta cell function is associated with the insulin secretion. Hence, this hypothesis may lead to new ways of improvement of glycaemic control.

Anonymous Patient Answer

Have there been other clinical trials involving intensification of insulin regimen/nutrition?

Based on the recent published study in this journal it can be concluded that intensive insulin therapy has a limited role in reducing HbA1c levels in type 2 diabetic patients without hyperglycemia/insulin resistance. It also has limited effect for improvement of body weight and glycemic control. Based on these results and the positive evidence from other relevant studies (ref-10), it cannot be definitively concluded whether intensified insulin therapy improves the long-term prognosis of type 2 diabetic patients. Therefore further well-designed prospective randomized controlled clinical trials are needed to establish the role of intensified insulin therapy in type 2 diabetic patients.

Anonymous Patient Answer

How does intensification of insulin regimen/nutrition work?

There appears to be no major improvement in hemoglobin glucose-A1c or glycemic episodes in the intensive treatment group compared with the standard regimen. More intensive diet should be continued, but a less intensive insulin regimen is recommended for those treated with insulin.

Anonymous Patient Answer

What is intensification of insulin regimen/nutrition?

Findings from a recent study suggest that intensification of insulin regimen, especially nutrition, do not decrease or increase the A1C compared to a basal insulin regimen. On the other hand, intensification of insulin dose and schedule with more frequent injections and more insulin can reduce A1C in diabetic subjects, especially subjects with poor glycemic control.

Anonymous Patient Answer
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