Whole Fruit and Blood Sugar in Type 2 Diabetes
This study is looking at how eating whole fruit affects blood sugar levels, liver fat, and heart health in adults with type 2 diabetes who are not taking insulin. Participants will gradually increase the amount of whole fruit they eat over 6.5 weeks until 50% of their daily calories come from whole fruit, and then continue this for the rest of the 17-week study. Researchers will measure your 24-hour and 3-hour blood sugar levels, as well as 3-hour insulin levels, to see the effects. You may be able to join if you are at least 18 years old, have type 2 diabetes with an HbA1c between 6.5-12.0%, and a fasting C-peptide level of 0.5 ng/ml or higher. The study is currently recruiting about 25 participants.
- Study design
- This is an interventional study with about 25 participants. It will test the effects of consuming whole fruit over 17 weeks.
- What's involved
- You would gradually increase your whole fruit intake over 6.5 weeks, then maintain a high whole fruit diet for the remaining study period. Blood sugar and insulin levels will be measured at the beginning and at week 17.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood sugar and insulin levels will be measured at the end of the 17-week study period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effects of Whole Fruit on Blood Sugar in People With Type 2 Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Courtney M Peterson · PRINCIPAL_INVESTIGATOR · Harvard School of Public Health (HSPH)
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mean 24-hour Glucose LevelsChange from baseline to week 17
Average 24-hour interstitial glucose levels (mg/dl), as measured by continuous glucose monitoring (CGM). If needed, data will be adjusted for any changes in antihyperglycemic medication use, using the medication effect score (MES).
- Mean 3-hour Glucose LevelsChange from baseline to week 17
Mean glucose (mg/dl) during a 3-hour oral glucose tolerance test (OGTT)
- Mean 3-hour InsulinChange from baseline to week 17
Mean insulin (mU/l) during a 3-hour OGTT
- Mean 3-hour C-PeptideChange from baseline to week 17
Mean C-Peptide (ng/ml) during a 3-hour OGTT
- Insulin SensitivityChange from baseline to week 17
Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model
- Dynamic Beta-Cell ResponsivityChange from baseline to week 17
Phi\_dynamic during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model (which is a set of 5 coupled differential equations; see reference under Citations). Phi\_dynamic is a measure of beta-cell responsiveness during first-phase insulin secretion. It is a dimensionless index (arbitrary units), where higher values denote greater insulin secretion
- Static Beta-Cell ResponsivityChange from baseline to week 17
Phi\_static during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model (which is a set of 5 coupled differential equations; see reference under Citations). Phi\_static is a measure of beta-cell responsiveness during second-phase insulin secretion. The units of measure are min\^-1, and higher values denote greater insulin secretion.
- Glycemic VariabilityChange from baseline to week 17
Measures of glucose variability derived from continuous glucose monitoring, including mean amplitude of glycemic excursions and standard deviation (mg/dl).
- Time-in-range Metrics from CGMChange from baseline to week 17
Standard time-in-range metrics, including time-below-range (TBR), time-in-range (TIR), and time-above-range (TAR), as standardized by the International Consensus on Time in Range. Values will be reported as percentages of the 24-hour day.