The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM (NCT02520050) | Clinical Trial Compass
CompletedNot Applicable
The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM
United States108 participantsStarted 2015-04
Plain-language summary
The American Diabetes Association (ADA), among other medical societies, is strongly recommending medical nutrition therapy (MNT) for prevention and management of type 2 diabetes. However, the ADA recognized that there is no "one size fits all" diet and thus recommends that MNT should be conducted through a consultation with registered dietitians (RD). Previous studies have shown that using diabetes-specific nutritional formulas, as an integral part of the MNT, lowers postprandial blood glucose levels. Through our experience from the Joslin's Weight Achievement and Intensive Treatment (Why WAIT™) program, applying MNT within a structured dietary intervention protocol has the best impact on blood glucose values and body weight. Meanwhile, the frequent use of health coaching during dietary intervention proved to be effective in managing diabetes and inducing weight loss. However, no study compared those three intervention methods in a randomized clinical study.
The aim of this study is to evaluate the effect of different models of conducting medical nutrition therapy on the glycemic control in patients with type 2 diabetes.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
. Subject states that he/she had type 2 diabetes, as evidenced by use of anti-hyperglycemic medication or managed on lifestyle intervention only with A1C \>7%
. Subject is between 30 and 80 years of age.
. Subject on stable dose of antihyperglycemic medications for the past 3 months or lifestyle intervention
. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If a female is of childbearing potential, she is practicing one of the following methods of birth control (and continued through the duration of the study):
. Subject's BMI is \> 25 kg/m2.
. Subject has A1C between 7-10%
Exclusion criteria
. Subjects using exogenous insulin since insulin titration may impact the primary endpoint.
. Subject states that he/she had a history of diabetic ketoacidosis.
. Subject is pregnant or lactating.
. Subject uses corticosteroid treatment with the exception of inhaled or topical steroids in the last 3 months; or antibiotics within the last 3 weeks prior to the screening visit.
. Subject states that he/she had an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
. Subject states that he/she has had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.
. Subject states that he/she has had end stage organ failure (such as end stage renal disease) or had status post organ transplant.
. Subject states that he/she has had a history of renal disease (Creatinine \>1.5mg/dL or GFR \<60 mL/min/1.73 m2).