Can a tailored diet and exercise program help with insulin resistance? small study tests feasibility
NCT ID NCT04392284
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a personalized lifestyle program could be run in a family medicine clinic for people with insulin resistance and related conditions like obesity, diabetes, and high blood pressure. Forty participants were randomly assigned to start with either nutrition counseling or exercise counseling. After 8 weeks, those who did not improve were given additional options, like weight-loss counseling or a prescription for metformin. The main goal was to see if such a program is feasible and acceptable to patients, not to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- diet counseling and exercise counseling
- What this could lead to
- If successful, this could lead to a practical, adaptable lifestyle program that doctors can use in family medicine clinics to help patients improve insulin resistance and metabolic health.
- What could go wrong
- This is a very small, early feasibility study with only 40 participants. It is not designed to prove the program works, only to see if it can be done. Results may not apply to everyone.
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
-
40 people
The number who actually took part.
- Started
-
Apr 2021
- Finished
-
Jun 2022
- 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
-
18 to 75 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 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: * Male or female * Any race or ethnicity * BMI \>27 kg/m2 * Presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., Stage 1 Obesity) * Prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease * Stable medication type and dosage for ≥3 months Exclusion Criteria: * If type 2 diabetes, * Currently prescribed metformin or prescribed within previous 3 months * HbA1c concentration of \>12% * Using exogenous insulin * Pregnant or lactating within the past 6 months or trying to become pregnant * Prescription for weight loss medications within the past 3 months * Severe obesity-related complications that require immediate and more intensive clinical therapy (e.g., pharmacotherapy and/or bariatric surgery) as determined by study physician and/or referring practitioner at UAB Family Medicine Clinic. * History of kidney disease that may increase the risk of lactic acidosis with metformin. * Currently prescribed the following medications that may increase the risk of lactic acidosis with metformin: acetazolamide (Diamox), dichlorphenamide (Keveyis), methazolamide, topiramate (Topamax, in Qsymia), or zonisamide (Zonegran). * Does not have a life-sustaining medical implant such as a pacemaker.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetes are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
UAB Highlands Family and Community Medicine Clinic
Birmingham, Alabama, 35205, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Very-Low-Carb diet reverse prediabetes? trial puts it to the test
- Gut bacteria may hold clues to dozens of diseases
- Heartbeat test aims to catch hidden nerve damage in diabetes
- Inflatable leg cuffs tested as a Two-for-One therapy for high blood pressure and erectile dysfunction
- Can Home-Delivered meals help control diabetes?
- Can nurses and home monitors tame high blood pressure?