Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02409238 : Insulin Resistance and Mild Cognitive Impairment (IRMCI) Study
PhasePhase 4
AgesMin: 55 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Chinese Singapore Citizen or Permanent Resident.

2. BMI of 23 or higher (Asian criteria for overweight and obese, Ministry of Health
Recommendation, Singapore); and Waist Circumference: ? 90cm and ? 80cm for Chinese
men and women respectively.

3. Prediabetes (if Not diabetic):

- Impaired fasting glucose (IFG): American Diabetes Association (ADA) criteria:
fasting plasma glucose level from 5.6 mmol/L (100 mg/dL) to 6.9 mmol/L (125
mg/dL), and/or

- Impaired glucose tolerance World Health Organization (WHO) and ADA criteria:
two-hour glucose levels of 140 to 199 mg per dL (7.8 to 11.0 mmol) on the 75-g
oral glucose tolerance test.

4. Type 2 Diabetes (if Not prediabetic) yet to be treated with anti-diabetic drug
treatment ('on diet control only'), with HbA1c ?7% OR Diabetics who have been taken
off medication for > 1 year with HbA1c< 7% will be considered for recruitment.

- If HbA1c is 7.1- 7.5% at any follow-up visit, then try diet and lifestyle
control and repeat at next visit (i.e. 3 months later). If the repeat HbA1c is
still 7.1% or higher, then take out of study and start medication.

- If HbA1c>7.5% at any time after Recruitment, take out of study and start
medication.

5. Mild Cognitive Impairment:

- The individual is neither normal nor demented;

- There is evidence of cognitive deterioration, shown by either objectively
measured decline over time or subjective report of decline by self or informant
in conjunction with objective cognitive deficits; and

- Activities of daily life are preserved and complex instrumental functions are
either intact or minimally impaired.

- This will be operationalized in the study as:

- A Subjective memory or cognitive complaint by the patient and/or by the
caregiver

- Objective cognitive deficit documented by performance on a battery of
multiple-domain neuropsychological tests (See below): a score that is 1.5
SD or more below age- and education-adjusted local norms

- aMCI: Deficit in delayed recall subtest of the Rey Auditory Verbal Learning Test
(RAVLT) and Story Memory test

- mdMCI: Deficit in language, executive function, visuospatial/constructional
ability, block design, and attention.

- Generally intact Activities of Daily Living as measured by Instrumental and
Basic Activities of Daily Living (IADL and BADL).

- No dementia:

Exclusion Criteria:

1. Contraindications to Metformin treatment: Creatinine of > 150umol/L, history of liver
disease or elevated hepatic transaminases Alanine Transaminase (ALT) or Aspartate
Aminotransferase (AST) >3 times Upper-Limit-of-Normal),

2. Severe Neuro-Musculoskeletal and Sensory Disabilities

3. Severe Psychiatric disorders (eg; alcohol abuse, severe depression, schizophrenia,
bipolar disorder)

4. Illnesses that seriously reduce life expectancy or ability to participate in the
trial

5. Congestive heart failure (New York Heart Association cardiac status classes 2, 3 or
4), Myocardial infarction or Coronary artery Bypass surgery or percutaneous coronary
intervention within the past 6 months, Cardiac Arrhythmias, Severe Hypertension.

6. Concurrent use or recent use (within 1 week or 5 half lives of the drug whichever is
longer) of drugs with anticholinesterase, sedating or central nervous system (CNS)
side effects: antispasmodics, antiemetics, antidiarrhoeals, antihistamines,
hypnotics, antidepressants, antipsychotics, bronchodilators.

7. Concurrent use of drugs (for >4 consecutive weeks) or use of drugs within 12 weeks of
screening) that are known to adversely affect glucose tolerance and its
interpretation: .

8. History of Hypersensitivity to any of the Study Drug or to Drugs of similar chemical
classes

9. Use of an Investigative Drug within 30 days or 5 half-lives of the drug whichever is
longer

10. Potentially Unreliable and/or judged by the investigator to be Unsuitable for the
study.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02409238      |      Link to official Clinicaltrials.gov listing
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