Which diet plan best tames type 2 diabetes? new study tests three approaches
NCT ID NCT02520050
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested three different diet plans in 108 overweight adults with type 2 diabetes to see which best improves blood sugar control. Participants followed either standard nutrition advice, a structured meal plan with special diabetes drinks, or that same structured plan plus weekly coaching from a dietitian. The goal was to find the most effective way to manage diabetes through diet.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dietary plans and meal replacements
- What this could lead to
- If successful, this could show which type of diet plan works best for managing type 2 diabetes and weight in overweight patients.
- What could go wrong
- This is a small, completed study with only 108 participants, so results may not apply to everyone. Diet studies are hard to control and rely on self-reporting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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108 people
The number who actually took part.
- Start date
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Apr 2015
- Finished
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Jul 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. 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% 3. Subject is between 30 and 80 years of age. 4. Subject on stable dose of antihyperglycemic medications for the past 3 months or lifestyle intervention 5. 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). 6. 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): * Condoms, sponge, diaphragm or intrauterine device; * Oral or parenteral contraceptives for 3 months prior to screening visit; * Vasectomized partner; * Total abstinence from sexual intercourse. 7. Subject's BMI is \> 25 kg/m2. 8. Subject has A1C between 7-10% 9. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on stable dose for at least three months prior to screening visit. These medications will not be changed during intervention unless it is mandatory. Exclusion Criteria: 1. Subjects using exogenous insulin since insulin titration may impact the primary endpoint. 2. Subject states that he/she had a history of diabetic ketoacidosis. 3. Subject is pregnant or lactating. 4. 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. 5. 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). 6. 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. 7. Subject states that he/she has had end stage organ failure (such as end stage renal disease) or had status post organ transplant. 8. Subject states that he/she has had a history of renal disease (Creatinine \>1.5mg/dL or GFR \<60 mL/min/1.73 m2). 9. Subject states that he/she has had current hepatic disease. 10. Subject has history of gastroparesis. 11. Subject states that he/she has had a chronic, contagious, infectious disease 12. Subject states that he/she has had clotting or bleeding disorders. 13. Subject is known to be allergic or intolerant to any ingredient found in the study products. 14. Subject is known to have a history of special nutritional need requiring special diet. 15. Subject is currently participating in any weight loss program. 16. Subject has used meal replacements during the 3 months prior to the start of the study. 17. Subject has history of bariatric surgery. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
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