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Which diet plan best tames type 2 diabetes? new study tests three approaches

NCT ID NCT02520050

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

108 people

The number who actually took part.

Start date

Apr 2015

Finished

Jul 2018

Lead sponsor

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

30 to 80 years

Sex

Anyone

Healthy volunteers

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

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

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.