Wednesday, December 31, 2025 12/31/2025

Glycemic reduction approaches in polycystic ovary syndrome: a comparative effectiveness study

Award Number: R01DK128205
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/15/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2026

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Glycemic reduction approaches in polycystic ovary syndrome: a comparative effectiveness study - ABSTRACT Polycystic ovary syndrome (PCOS) is the most common endocrine disorder for women of reproductive age. Women with PCOS are at a high risk of health complications. In fact, women with PCOS have a 3-7 times higher risk for type 2 diabetes, and obese women with PCOS have an even higher risk of type 2 diabetes. Experts recommend that the first-line treatment for overweight and obese women with PCOS should be diet and lifestyle interventions. Yet, experts disagree about the specific nutritional advice these interventions should encourage, with different groups recommending no particular diet, a high-carbohydrate Dietary Approaches to Stop Hypertension (DASH) diet, or a lower carbohydrate diet. A systematic review of previous dietary trials in PCOS did find a slight benefit of lower carbohydrate diets for glucose control, weight loss, insulin, and insulin resistance. This may be because carbohydrate intake raises glucose levels, which in turn increases insulin secretion. Insulin then stimulates ovarian androgen production and inhibits the release of fatty acids from cells. Previous research in type 2 diabetes suggests that not simply lower carbohydrate intake, but a very low- carbohydrate (VLC) diet, with less than 20% of calories from carbohydrates, designed to reduce body weight and glucose levels more significantly than other types of lower carbohydrate diets, would be even more effective for improving metabolic health in PCOS. Although reviews note that a VLC diet has shown promise for type 2 diabetes, prediabetes, obesity, and cardiovascular risk, evidence for PCOS is only emerging. In our recently completed 4-month trial of 29 overweight or obese women with PCOS following a VLC diet, we found significant improvements in outcomes, including glycated hemoglobin (HbA1c; -0.21%) and body weight (-7.7%). We propose a 12-month randomized, controlled trial for 184 overweight or obese (BMI of 28-55 kg/m2) adults with PCOS comparing a VLC diet and a standard-of-care low-fat, Dietary Approaches to Stop Hypertension (DASH) diet. The program for both groups is delivered online, as in our pilot study. Aim 1: To compare changes in glycemic control. We hypothesize that the VLC version will lead to greater improvements in HbA1c at 12-months. Aim 2: To compare changes in secondary health outcomes tied to type 2 diabetes risk, including glycemic variability, conversion to normoglycemia, body weight, and body fat percentage. We hypothesize that the VLC version will lead to greater improvements in secondary health outcomes at 12- months. Aim 3: To explore intervention satisfaction and acceptability. The guiding objective of this proposal is to explore a novel diet and lifestyle approach for reducing the future risk of type 2 diabetes for overweight or obese women with PCOS. We anticipate that the proposed research will have an important impact on diet and lifestyle recommendations for this high-risk, understudied population.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $562,477 )
2026	2026	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	12/17/2025	NON-COMPETING CONTINUATION	$562,477
														Subtotal = $562,477

Issue Date FY: 2025 ( Subtotal = $548,100 )
2025	2025	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	11/28/2024	NON-COMPETING CONTINUATION	$548,100
														Subtotal = $548,100

Issue Date FY: 2024 ( Subtotal = $597,901 )
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	12/7/2023	NON-COMPETING CONTINUATION	$560,532
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	5/7/2024	NON-COMPETING CONTINUATION	$37,369
														Subtotal = $597,901

Issue Date FY: 2023 ( Subtotal = $613,275 )
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON STREET	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	1/31/2023	NON-COMPETING CONTINUATION	$61,327
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/7/2022	NON-COMPETING CONTINUATION	$551,948
														Subtotal = $613,275

Issue Date FY: 2022 ( Subtotal = $639,848 )
2022	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	2/14/2022	NEW	$0
2022	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	12/14/2021	NEW	$639,848
														Subtotal = $639,848

Grand Total All Awards = $2,961,601

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Glycemic reduction approaches in polycystic ovary syndrome: a comparative effectiveness study

Award Number: R01DK128205

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/15/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2026

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