Trial Outcomes & Findings for Return of First-phase Insulin Secretion in Type 2 Diabetes is Associated With Depletion of Pancreas Lipid (NCT NCT03430310)

NCT ID: NCT03430310

Last Updated: 2024-10-24

Results Overview

Assessing the overall percentage of liver fat with magnetic resonance imaging (MRI) to measure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: Baseline, week 12
• Results posted on: 2024-10-24

Participant Flow

Recruitment period was between September 2018 and March 2023. Recruitment methods included flyers, local advertisements, radio, tv, social media, and word of mouth.

No washout or run-in was used for this study.

Participant milestones

Measure	Low Glycemic Diet The investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. Participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish.	Control Diet The Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide \<2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet.
Overall Study STARTED	32	33
Overall Study COMPLETED	27	30
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	Low Glycemic Diet The investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. Participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish.	Control Diet The Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide \<2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet.
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	3	2
Overall Study COVID shutdown March 2020	0	1

Baseline Characteristics

Return of First-phase Insulin Secretion in Type 2 Diabetes is Associated With Depletion of Pancreas Lipid

Baseline characteristics by cohort

Measure	Low Glycemic Diet n=32 Participants The investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. Participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish.	Control Diet n=33 Participants The Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide \<2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet.	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=93 Participants	31 Participants n=4 Participants	63 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	25 Participants n=4 Participants	51 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	8 Participants n=4 Participants	14 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	12 participants n=93 Participants	11 participants n=4 Participants	23 participants n=27 Participants
Race/Ethnicity, Customized African American	20 participants n=93 Participants	22 participants n=4 Participants	42 participants n=27 Participants
Region of Enrollment United States	32 participants n=93 Participants	33 participants n=4 Participants	65 participants n=27 Participants
BMI	34.94 kg/m^2 STANDARD_DEVIATION 6.06 • n=93 Participants	35.90 kg/m^2 STANDARD_DEVIATION 6.60 • n=4 Participants	35.43 kg/m^2 STANDARD_DEVIATION 6.31 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline, week 12

Assessing the overall percentage of liver fat with magnetic resonance imaging (MRI) to measure

Outcome measures

Measure	Low Glycemic Diet n=27 Participants The investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. Participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish.	Control Diet n=30 Participants The Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide \<2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet.
Changes in Liver Fat	5.4 percent liver fat Standard Error 0.7	7.3 percent liver fat Standard Error 0.6

Adverse Events

Low Glycemic Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Barbara Gower, PhD

The University of Alabama at Birmingham

Phone: 205-934-4087

Email: bgower@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place