Effects of a Dulaglutide plus Calorie-Restricted Diet versus a Calorie-Restricted Diet on Visceral Fat and Metabolic Profiles in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial.

Zhang Y, Qu Z, Lu T, Shao X, Cai M, Dilimulati D, Gao X, Mao W, Hu F, Su L, Liao Q, Han T, Zhang M, Qu S

Nutrients20 Jan 2023Cited by 34 (Europe PMC)

PMID36771262PMCIDPMC9920202DOI10.3390/nu15030556PepBankPUB-36771262

Summary

The effects of dulaglutide and a calorie-restricted diet (CRD) on visceral adipose tissue (VAT) and metabolic profiles in polycystic ovary syndrome (PCOS) have not been extensively investigated. In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women. Between May 2021 and May 2022, this single-center, randomized, controlled, open-label clinical trial was conducted. Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months. The primary endpoint was the difference in the change in VAT area reduction between the groups. The secondary endpoints contained changes in menstrual frequency, metabolic profiles, hormonal parameters, liver fat, and body composition. As compared with the CRD group, the dulaglutide + CRD group had a considerably shorter median time to achieve 7% weight loss. There was no significant between-group difference in area change of VAT reduction (-0.97 cm², 95% confidence interval from -14.36 to 12.42, p = 0.884). As compared with CRD alone, dulaglutide + CRD had significant advantages in reducing glycated hemoglobin A1c and postprandial plasma glucose levels. The results of the analyses showed different changes in menstruation frequency, additional metabolic profiles, hormonal markers, liver fat, and body composition between the two groups did not differ significantly. Nausea, vomiting, constipation, and loss of appetite were the main adverse events of dulaglutide. These results emphasize the value of dietary intervention as the first line of treatment for PCOS-affected women, while glucagon-like peptide 1 receptor agonist therapy provides an efficient and typically well tolerated adjuvant therapy to aid in reaching weight targets based on dietary therapy in the population of overweight/obese PCOS-affected women.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In women with PCOS, visceral fat area reduction did not differ between dulaglutide plus diet and diet alone.
In plain wordsIn women with PCOS, dulaglutide plus diet did not reduce visceral fat more than diet alone.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeVisceral adipose tissue area
Study
n = 68
Comparator
Calorie-restricted diet alone
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated
Measurements
Between-group difference in VAT area change
−0.97 cm<sup>2</sup>
dulaglutide + CRD vs CRD
95% confidence interval of VAT area change difference
−14.36 to 12.42 cm<sup>2</sup>
dulaglutide + CRD vs CRD
p value
0.884
VAT area change, between groups
Source sentences
Summary
There was no significant between-group difference in area change of VAT reduction (-0.97 cm², 95% confidence interval from -14.36 to 12.42, p = 0.884).
2 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126202
02HumanRandomized controlled trialEfficacy outcome
In women with PCOS, dulaglutide plus diet reduced HbA1c more than diet alone.
In plain wordsIn women with PCOS, dulaglutide plus diet reduced HbA1c more than diet alone.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c
Study
n = 68
Comparator
Calorie-restricted diet alone
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
As compared with CRD alone, dulaglutide + CRD had significant advantages in reducing glycated hemoglobin A1c and postprandial plasma glucose levels.
3 context sentences(design, population, supporting numbers)
Summary · context
The secondary endpoints contained changes in menstrual frequency, metabolic profiles, hormonal parameters, liver fat, and body composition.
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126203
03HumanRandomized controlled trialEfficacy outcome
In women with PCOS, dulaglutide plus diet reduced postprandial glucose more than diet alone.
In plain wordsIn women with PCOS, dulaglutide plus diet reduced glucose after meals more than diet alone.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreasePostprandial plasma glucose
Study
n = 68
Comparator
Calorie-restricted diet alone
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
As compared with CRD alone, dulaglutide + CRD had significant advantages in reducing glycated hemoglobin A1c and postprandial plasma glucose levels.
3 context sentences(design, population, supporting numbers)
Summary · context
The secondary endpoints contained changes in menstrual frequency, metabolic profiles, hormonal parameters, liver fat, and body composition.
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126204
04HumanRandomized controlled trialEfficacy outcome
In women with PCOS, menstruation, additional metabolic profiles, hormonal markers, liver fat, and body composition did not differ between treatments.
In plain wordsIn women with PCOS, these additional outcomes did not differ between dulaglutide plus diet and diet alone.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeOther clinical and metabolic outcomes
Study
n = 68
Comparator
Calorie-restricted diet alone
Analysis
Secondary
Outcome group
Metabolic pathways and metabolomics · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
The results of the analyses showed different changes in menstruation frequency, additional metabolic profiles, hormonal markers, liver fat, and body composition between the two groups did not differ significantly.
3 context sentences(design, population, supporting numbers)
Summary · context
The secondary endpoints contained changes in menstrual frequency, metabolic profiles, hormonal parameters, liver fat, and body composition.
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126205
05HumanRandomized controlled trialEfficacy outcome
In overweight or obese women with PCOS, adding dulaglutide to calorie restriction shortened the time to 7% weight loss.
In plain wordsIn women with PCOS, dulaglutide plus diet reached the weight goal faster than diet alone.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseTime to weight loss target
Study
n = 68
Comparator
Calorie-restricted diet alone
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
As compared with the CRD group, the dulaglutide + CRD group had a considerably shorter median time to achieve 7% weight loss.
2 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126201
06HumanRandomized controlled trialSafety outcome
In women with PCOS, nausea was a main adverse event during dulaglutide treatment.
In plain wordsIn women with PCOS, nausea occurred during dulaglutide treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableNausea
Study
n = 35
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Nausea, vomiting, constipation, and loss of appetite were the main adverse events of dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126206
07HumanRandomized controlled trialSafety outcome
In women with PCOS, vomiting was a main adverse event during dulaglutide treatment.
In plain wordsIn women with PCOS, vomiting occurred during dulaglutide treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableVomiting
Study
n = 35
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Nausea, vomiting, constipation, and loss of appetite were the main adverse events of dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126207
08HumanRandomized controlled trialSafety outcome
In women with PCOS, constipation was a main adverse event during dulaglutide treatment.
In plain wordsIn women with PCOS, constipation occurred during dulaglutide treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableConstipation
Study
n = 35
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Nausea, vomiting, constipation, and loss of appetite were the main adverse events of dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126208
09HumanRandomized controlled trialSafety outcome
In women with PCOS, appetite loss was a main adverse event during dulaglutide treatment.
In plain wordsIn women with PCOS, appetite loss occurred during dulaglutide treatment.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableLoss of appetite
Study
n = 35
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Nausea, vomiting, constipation, and loss of appetite were the main adverse events of dulaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
In this study, we investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits as compared with a CRD regimen alone in overweight or obese PCOS-affected women.
Summary · context
Overall, 243 participants with PCOS were screened, of which 68 overweight or obese individuals were randomly randomized to undergo dulaglutide combined with CRD treatment (n = 35) or CRD treatment alone (n = 33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months.
Show in the study text Report a problemFND-3677126209

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Version history

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Version 2Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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